ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care
C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with T3, T4, or node-positive non-metastatic rectal cancer.
Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.
Participants must be 18 years of age or older.
ECOG 0-2.
Disqualifiers
Participants must not have any other organ cancer evident at the time of enrollment.
Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
Participants must not be actively or planning to be pregnant or breastfeeding
Trial population
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ctDNA
Other interventioninitial research biopsy, quality of life assessments and ctDNA collection
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: EVALUATION OF CTDNA1 intervention
Trial outcomes
Primary outcomes
1
Rate of successful non-operative management
Time frame
1 year2
Rate of successful pathologic complete response
Time frame
1 yearSecondary outcomes
1
Rate of local recurrence
Local recurrence is defined as cancer coming back is in the same place as the original cancer or very close to it. Local recurrence will be assessed in participants who achieved a Clinical Complete Response (cCR) or Near Complete Clinical Response (nCR) after rectal cancer treatment by ctDNA status with the C2i assay.
Time frame
5 years2
EORTC-QLQ-CR 29 questionnaire
European Organization for Research and Treatment of Cancer-Colorectal surgery (EORTC-QLQ-CR 29) is a 29-item patient-reported questionnaire to assess health-related quality of life in patients with colorectal cancer. Each question ranges in score from 1 to 4. Higher scores indicate higher levels of symptoms or less functioning.
Time frame
Up to 30 months3
FACT-C questionnaire
Functional Assessment of Cancer Therapy- Colorectal (FACT-C) is a 37-item patient-reported questionnaire to assess quality of life in patients with colorectal. FACT-C questions are divided into four primary quality of life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Participants rate each item on the questionnaire from 0 to 4. Total score range is from 0 to 136. Higher scores generally indicate better quality of life.
Time frame
Up to 30 months4
IADL Scale
Instrumental Activities of Daily Living (IADL) Scale is an 8-item patient-reported questionnaire with a summary score from 0 (low function) to 8 (high function). IADLs are things you do every day to independently take care of yourself and your home.
Time frame
Up to 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
C2i Genomics
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: