ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

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 years

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 months

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 months

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 months

Brief Pain Inventory (BPI) questionnaire

Brief Pain Inventory (BPI) is a questionnaire to measure the severity and interference of pain on daily functions in participants with cancer. BPI scale total score: * worst pain score: 1-4 = mild pain * worst pain score: 5-6 = moderate pain * worst pain score: 7-10 = severe pain

Time frame: Up to 30 months

Bowel function assessment with LARS score

Low Anterior Resection Syndrome (LARS) score (LARS) is a 5-item questionnaire to assess bowel dysfunction following a low anterior resection for rectal cancer. LARS total score: * 0-20 = no dysfunction * 21-29 = minor dysfunction * 30-42 = major dysfunction

Time frame: Up to 30 months

Bowel function assessment with FISI score

Fecal Incontinence Severity Index (FISI) is a patient-reported questionnaire that helps quantify the impact of adult incontinence leakage on quality of life. Total score range is from 0 to 61. Higher scores indicate a higher perceived severity of fecal incontinence and related impact on quality of life.

Time frame: Up to 30 months

Bowel function assessment with FIQOL score

Fecal Incontinence Quality of Life (FIQOL) is a 29-item patient-reported questionnaire to assess quality of life of participants with fecal incontinence. The questionnaire has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5 and are the average response to all items on each scale. Total FIQOL score is the sum of all four subscales. Lower scores indicate lower functional status and related quality of life.

Time frame: Up to 30 months

Disease-free survival (DFS)

Disease-free survival (DFS) is defined as the length of time after completion of rectal cancer treatment that the patient survives without any signs or symptoms of that cancer.

Time frame: Up to 30 months

Overall Survival (OS)

Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive.

Time frame: Up to 30 months