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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01242 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RG1001786 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to low accrual
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| Name | Class |
|---|---|
| Minnesota Ovarian Cancer Alliance | OTHER |
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The goal of this project is to develop a minimally invasive test to detect ovarian cancer, by searching for mutations from the tumor in samples obtained from the cervix (Pap smears), and from the uterus (uterine lavage) in participants with advanced ovarian cancer and in participants with increased risk of ovarian cancer due to inherited mutations, such as BRCA or BRCA2 (among others).
Pap smear and uterine lavage samples will be collected while the participant is under anesthesia for planned debulking surgery. A novel, highly sensitive and accurate technique, Crispr-Duplex sequencing, will be used to detect tumor associated mutations in TP53 (the most commonly mutated gene in ovarian cancer) within these samples. These results will be compared to sequencing results in the tumor itself for comparison, and Pap and uterine lavage will be compared to each other to determine the optimal test. Ultimately, the goal is to use the results of this study to plan a larger study including women without cancer who are at either increased risk or normal risk of ovarian cancer, for use in early detection.
OUTLINE:
Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (pap smear, uterine lavage, tumor sample) | Experimental | Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Other | Undergo collection of tumor sample and blood draw |
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| Measure | Description | Time Frame |
|---|---|---|
| 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage | In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer. | A single point in time after sample collection, no follow-up of participants is done |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara S. Norquist | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Rosana Risques | 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 | Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) | Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Duplex sequencing. Biospecimen Collection: Undergo collection of tumor sample Laboratory Biomarker Analysis: Correlative studies Lavage: Undergo uterine lavage Pap Smear: Undergo pap smear |
| 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 | Yes | No | No | Study Protocol | Nov 9, 2023 | Dec 4, 2023 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Lavage | Device | Undergo uterine lavage |
|
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| Pap Smear | Other | Undergo pap smear |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) | Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing. Biospecimen Collection: Undergo collection of tumor sample and blood draw Laboratory Biomarker Analysis: Correlative studies Lavage: Undergo uterine lavage Pap Smear: Undergo pap smear |
| 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 | >=18 years | Count of Participants | Participants |
| |||||||||||||||||||
| 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 | Number | 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 | 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage | In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer. | We were able to enroll 20 participants who ended up having ovarian cancer. We recruited less than expected due to the COVID19 pandemic and increased use of neoadjuvant chemotherapy. | Posted | Count of Participants | Participants | A single point in time after sample collection, no follow-up of participants is done |
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At the time of sample collection (during surgery).
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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 | Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) | Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing. Biospecimen Collection: Undergo collection of tumor sample and blood draw Laboratory Biomarker Analysis: Correlative studies Lavage: Undergo uterine lavage Pap Smear: Undergo pap smear | 0 | 52 | 0 | 52 | 0 | 52 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Norquist | University of Washington | 206-543-3669 | bnorquis@uw.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2023 | Dec 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D065006 | Papanicolaou Test |
| D014626 | Vaginal Smears |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D013514 | Surgical Procedures, Operative |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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| Unknown or Not Reported |
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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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