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Funding
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| Name | Class |
|---|---|
| Clinical Genomics | UNKNOWN |
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In this research study, the investigators are looking to see if the circulating tumor DNA (genetic material), also known as ctDNA, in the blood will help them predict whether the participant's cancer will come back.
In this research study, the investigator are performing blood draws to see if the presence or absence of circulating tumor DNA (ctDNA), the genetic material in the participant's cancer's cells, will help the investigators predict whether the participant's cancer will come back or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor Sequencing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Functional Assessment of Cancer Therapy- Colorectal | Other | The Functional Assessment of Cancer Therapy- Colorectal (FACT-C) questionnaire measures health-related quality of life for people with chronic illnesses. |
| Measure | Description | Time Frame |
|---|---|---|
| One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA | Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate at any time up to 5 years in patients who have achieved a clinical complete response after rectal cancer treatment but who test positive for circulating tumor DNA at study entry | Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition. |
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Inclusion Criteria:
Exclusion Criteria:
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This prospective, observational, non-interventional study will enroll patients who have achieved a clinical complete response after treatment for rectal cancer and are undergoing standard surveillance.
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| Name | Affiliation | Role |
|---|---|---|
| Theodore S Hong, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02214 | United States | ||
| Beth Israel Deaconess Medical Center |
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| 5 years |
| Overall rate of local recurrence by stratified KRAS/BRAF status and possibly other gene targets | Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition. | 5 years |
| Median EORTC QLQ-CR29 Score | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) for Colorectal cancer(CR) 29 item questionnaire. The survey will be given at baseline, 6, 12, and 24 months. Results will be reported as the median score for each question. A score of 1 represents 'Not at All' and 4 represents 'Very Much'. | Baseline, 6 months, 12 months, 24 months |
| Median SF-12 Health Survey Score | The SF-12 is a 12 item validated questionnaire that assesses a participants view of their health. Scores will be normalized on a 100 point scale with higher scores representing better health. | Baseline, 6 months, 12 months, 24 months |
| Median LARS Score | The Low Anterior Resection Syndrome (LARS) Score is used to assess bowel dysfunction. The survey is assessed on a scale of 0-42 points, with a higher score indicating worse bowel dysfunction. | Baseline, 6 months, 12 months, 24 months |
| Median FIQOL Score | Fecal Incontinence Quality of Life (FIQOL) Score. Lower scores represent lower functional status. | Baseline, 6 months, 12 months, 24 months |
| Median Fecal Incontinence Severity Index (FISI) score | The FISI measures incontinence for gas, mucus, liquid stool,and solid stool. The survey assesses the number of times per day that the participant experiences incontinence for gas, mucus, liquid stool,and solid stool. Higher scores represent a higher degree of fecal incontinence. | Baseline, 6 months, 12 months, 24 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Brigham and Women Hospital | Boston | Massachusetts | 02215 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02459 | United States |