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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| NCI-2020-05021 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10544 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies the safety and feasibility of utilizing acupuncture in patients with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the immune system in the treatment of bladder cancer. Unfortunately, many patients experience side effects such as pelvic pain, painful urination, severe urgency, frequency, urge incontinence, need to urinate at night, and/or infectious complications. These side effects may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in which fine metallic needles are inserted into anatomical locations of the body to stimulate the peripheral and the central nervous system. Giving acupuncture before each intravesical BCG treatment may help to reduce the side effects of intravesical BCG, and help patients complete treatment. Specific outcomes of interest include acceptability to patients, effect of acupuncture on intravesical BCG-related side effects, and adverse events associated with acupuncture.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.
ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.
After completion of study, patients are followed up at 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (acupuncture, BCG) | Experimental | Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. |
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| Arm II (BCG, standard of care) | Active Comparator | Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture Therapy | Device | Undergo acupuncture therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled | Will be described via qualitative report. | Up to 1 week after completion of treatment, an average of 7 weeks |
| Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction. | Baseline, up to 1 week after completion of treatment, an average of 7 weeks |
| Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm. | Up to 1 week after completion of treatment, an average of 7 weeks |
| Patient Satisfaction | Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test. | At 3 weeks and after completion of treatment, an average of 7 weeks |
| Clinic Staff's Responses to Surveys | Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report | Up to 1 week after completion of treatment, an average of 7 weeks |
| Number of Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| BCG Instillation Adherence (Out of a Possible Planned Six Treatments) | BCG instillation adherence (successful adherence defined as the number of successfully administered BCG instillations of a possible 6 total) and weeks missed (measured as total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG). Results between the acupuncture and control arms will be compared via t-test. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who have had intravesical or systemic chemotherapy or radiation therapy for bladder cancer or for other malignancies prior to entering the study
Subjects who are indicated to receive other intravesical agents or therapies concurrently with BCG will be excluded
Subjects who have muscle-invasive bladder cancer, radiographic evidence of lymph node metastases or metastatic disease involving other organs including brain metastases
Patients with predominant histology other than urothelial carcinoma of the bladder who would not otherwise be considered candidates for BCG
BCG is contraindicated in:
Not pregnant or trying to become pregnant. Acupuncture points included in the protocol are contraindicated with pregnancy
Does not have a pacemaker. There is potential of electrostimulation interfering with the operation and function of pacemakers
Patients requiring chronic treatment with certain antibiotics that may interfere with the effectiveness of BCG. Fluoroquinolone therapy may decrease the efficacy of intravesical BCG. Antibiotic therapy for ongoing treatment of active tuberculosis will decrease the efficacy of intravesical BCG
Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded. Acupuncture points included in the protocol are contraindicated with pregnancy and BCG is contraindicated in pregnancy
Pacemaker. Patients with pacemakers are restricted due to the potential of electrostimulation interfering with a pacemakers operation
Platelets: < 20,000/ uL. Risk of bleeding with acupuncture
ANC: < 500 cells/uL. Risk of infection with acupuncture
Received acupuncture in the previous 3 months. Acupuncture treatment effects persist after a course of treatment, previous exposure to the intervention has the potential to affect the baseline data for treatment and control arms
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| Name | Affiliation | Role |
|---|---|---|
| Sarah P. Psutka | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Acupuncture, BCG) | Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Acupuncture Therapy: Undergo acupuncture therapy BCG Solution: Given by intravesical injection Best Practice: Receive standard of care symptom management Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2021 |
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| BCG Solution | Biological | Given by intravesical injection |
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| Best Practice | Other | Receive standard of care symptom management |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care. |
| Up to 1 week after completion of treatment, an average of 7 weeks |
| Up to 1 week after completion of treatment, an average of 7 weeks |
| Bladder and Bowel Symptoms as Self Reported by Patients | Assessed using the EORTC - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. | From week 1 to week 6 of treatment |
| Quality of Life: EORTC-QLQ-C30 | Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30). All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. | From week 1 to week 6 of treatment |
| Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types | Will be compared via Wilcoxon rank sum test. | Up to 1 week after completion of treatment, an average of 7 weeks |
| FG001 | Arm II (BCG, Standard of Care) | Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. Acupuncture Therapy: Undergo acupuncture therapy BCG Solution: Given by intravesical injection Best Practice: Receive standard of care symptom management Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| COMPLETED |
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| NOT COMPLETED |
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Some patients signed the consent but couldn't start the treatment because of progression of disease, those data were not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Acupuncture, BCG) | Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Acupuncture Therapy: Undergo acupuncture therapy BCG Solution: Given by intravesical injection Best Practice: Receive standard of care symptom management Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG001 | Arm II (BCG, Standard of Care) | Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. Acupuncture Therapy: Undergo acupuncture therapy BCG Solution: Given by intravesical injection Best Practice: Receive standard of care symptom management Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| Tumor stage | Pathologic stage Ta: Presence of a papillary tumor that does not infiltrate the bladder wall. Tis: The existence of carcinoma in situ, which constitutes a non-invasive flat high-grade (G3) cancer. T1: Tumor penetration into the connective tissue beneath the surface lining. All other stages were excluded. Ta is the least aggressive, and Tis and T1 are the most aggressive. Please note these were not outcomes, but were inclusion criteria for patients who would be eligible to receive induction BCG and therefore would be candidates for study entry. | Count of Participants | Participants |
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| Charlson Comorbidity Index | "The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was." | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) performance status | Eastern Cooperative Oncology Group (ECOG) performance status criteria is used to assess how a patient's disease is progressing and to assess how the disease affects the daily living abilities of the patient. The scores on this instrument range from 0-5 (0=fully active and 5=dead), with higher scores indicating poorer performance. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled | Will be described via qualitative report. | Posted | Count of Participants | Participants | Up to 1 week after completion of treatment, an average of 7 weeks |
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| Primary | Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing) | Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction. | Posted | Count of Participants | Participants | Baseline, up to 1 week after completion of treatment, an average of 7 weeks |
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| Primary | Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why) | Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm. | Posted | Count of Participants | Participants | Up to 1 week after completion of treatment, an average of 7 weeks |
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| Primary | Patient Satisfaction | Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test. | Data were not collected | Posted | At 3 weeks and after completion of treatment, an average of 7 weeks |
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| Primary | Clinic Staff's Responses to Surveys | Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report | Data were not collected | Posted | Up to 1 week after completion of treatment, an average of 7 weeks |
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| Primary | Number of Adverse Events | BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care. | The number of AEs are not mutually exclusive and participants may have reported more than one AE | Posted | Count of Units | Adverse Events | Up to 1 week after completion of treatment, an average of 7 weeks | Adverse Events | Adverse Events |
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| Secondary | BCG Instillation Adherence (Out of a Possible Planned Six Treatments) | BCG instillation adherence (successful adherence defined as the number of successfully administered BCG instillations of a possible 6 total) and weeks missed (measured as total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG). Results between the acupuncture and control arms will be compared via t-test. | Posted | Median | Inter-Quartile Range | Visits | Up to 1 week after completion of treatment, an average of 7 weeks |
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| Secondary | Bladder and Bowel Symptoms as Self Reported by Patients | Assessed using the EORTC - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. | Posted | Median | Inter-Quartile Range | score on a scale | From week 1 to week 6 of treatment |
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| Secondary | Quality of Life: EORTC-QLQ-C30 | Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30). All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. | Posted | Median | Inter-Quartile Range | score on a scale | From week 1 to week 6 of treatment |
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| Secondary | Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types | Will be compared via Wilcoxon rank sum test. | Data were not collected | Posted | Up to 1 week after completion of treatment, an average of 7 weeks |
|
Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
Toxicity or AEs related to BCG administration were collected by patient survey on a weekly basis using the CTCAE v.50 assessment of Systemic Therapy Toxicity. Patients in the acupuncture arm were surveyed weekly prior to acupuncture treatments regarding side effects and potential adverse events associated with the acupuncture intervention using the CTCAE v5. There were two acupuncture-related adverse events: 1 patient reporting a Grade 1 bruise and 1 patient reporting a Grade 1 pain.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Acupuncture, BCG) | Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Acupuncture Therapy: Undergo acupuncture therapy BCG Solution: Given by intravesical injection Best Practice: Receive standard of care symptom management Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 26 | 0 | 26 | 24 | 26 |
| EG001 | Arm II (BCG, Standard of Care) | Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. Acupuncture Therapy: Undergo acupuncture therapy BCG Solution: Given by intravesical injection Best Practice: Receive standard of care symptom management Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 14 | 0 | 14 | 14 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise | Injury, poisoning and procedural complications | Systematic Assessment |
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| Bowel Symptoms | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Flu-like Symptoms | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urinary Symptoms | Renal and urinary disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Psutka, MD, MS | University of Washington | 206-598-4294 | spsutka@uw.edu |
| Jul 31, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2021 | Nov 23, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Former |
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| Current |
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| Unknown |
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| pTa |
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| pT1 |
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| Unknown |
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| 1 |
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| 2 or greater |
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| 1 |
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| 2 |
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| Regulatory hold 12/17/21-1/13/22 |
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