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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-31

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Malignancies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tumor Sequencing

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

The Functional Assessment of Cancer Therapy- Colorectal

Intervention Type OTHER

The Functional Assessment of Cancer Therapy- Colorectal (FACT-C) questionnaire measures health-related quality of life for people with chronic illnesses.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No