A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal Cancer

Mass General Brigham

Status: Withdrawn

Conditions: Gastrointestinal Malignancies

Treatments: Other: The Functional Assessment of Cancer Therapy- Colorectal

Study type: Observational

Funder types: Other

Identifiers

NCT03749083

18-304

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have achieved a clinical complete response (cCR) within 3 months of last therapy - defined as absence of residual ulceration, mass or mucosal irregularity at endoscopic assessment - following neoadjuvant therapy with chemoradiation or chemotherapy followed by radiation for stage I, II, or III non-metastatic rectal cancer. (Whitening of the mucosa with presence of telangiectasia will be accepted as cCR.)
• Participants must have original tumor tissue (formalin-fixed, paraffin-embedded specimens) available for analysis
• Participants must be 18 years of age or older.
• Participants must be able to understand and willing to sign a written informed consent document.
• Participants must have received long course chemoradiation to 40-54 Gy.
• Participants must have received at least 4 cycles of FOLFOX
• Participant must be no more than 3 months past the conclusion of initial chemoradiation of rectal cancer (i.e., end of chemoradiation).

Exclusion criteria

• Participants may 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.

Trial design

0 participants in 1 patient group

Tumor Sequencing

Description:

Quality of life assessments will be collected using The Functional Assessment of Cancer Therapy- Colorectal Blood for circulating tumor DNA will be collected

Treatment:

Other: The Functional Assessment of Cancer Therapy- Colorectal