An observational study in Gastrointestinal Malignancies, sponsored by Massachusetts General Hospital. Withdrawn at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by Massachusetts General Hospital · Observational
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
Browse Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
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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.
Exclusion Criteria:
* Quality of life assessments will be collected using The Functional Assessment of Cancer Therapy- Colorectal * Blood for circulating tumor DNA will be collected
Other: The Functional Assessment of Cancer Therapy- Colorectal
The Functional Assessment of Cancer Therapy- Colorectal (FACT-C) questionnaire measures health-related quality of life for people with chronic illnesses.
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months, 12 months, 24 months
Median FIQOL Score
Fecal Incontinence Quality of Life (FIQOL) Score. Lower scores represent lower functional status.
Time frame: 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.
Time frame: Baseline, 6 months, 12 months, 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital