Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biopsy, Biospecimen Collection, Electronic Health Record Review.
- Who it may be relevant to
- Registry conditions: Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.
Detailed description
PRIMARY OBJECTIVE:
I. To estimate the percentage of participants that achieve complete clinical response.
SECONDARY OBJECTIVES:
I. To assess circulating tumor deoxyribonucleic acid (ctDNA) status among participants receiving total neoadjuvant therapy (TNT).
II. To assess molecular residual disease (MRD i.e., ctDNA status). III. To assess the rate of transabdominal surgery. IV. To assess the rate pathological complete response after surgery. V. To assess the rate of watch and -wait (W\&W) after TNT. VI. To assess disease-free survival (DFS). VII. To assess overall survival (OS).
EXPLORATORY OBJECTIVES:
I. To characterize ctDNA clearance or non-clearance patterns during TNT. II. To correlate ctDNA levels with a participant's pathological features. III. To preliminary assess the prognostic performance of ctDNA levels in relation to participant's clinical outcome.
OUTLINE:
Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available.
Interventions
- Procedure Biopsy
Undergo biopsy - Procedure Biospecimen Collection
Undergo collection of blood and/or tissue samples - Other Electronic Health Record Review
Medical records are reviewed
Primary outcome measures
- Complete clinical response (cCR) [Time frame: From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months.]
Secondary outcome measures (7)
- Positive circulating tumor deoxyribonucleic acid (ctDNA) [Time frame: From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years.]
- Positive ctDNA after completing TNT [Time frame: From date of baseline measure of ctDNA (i.e., number of mutant molecules per mL) to date of until the date of first documented progression, up to 3 years]
- Rate of transabdominal surgery [Time frame: Up to 3 years following completion of TNT]
- Rate of pathological complete response (pCR) [Time frame: From start of treatment until completion of surgery, up to 3 years.]
- Rate of watch and wait strategy [Time frame: Up to 3 years following completion of TNT]
- Disease-free survival [Time frame: Time between the date of surgery (or W&W population, the date of completing TNT) and the date of local or metastatic recurrence or death from any cause, assessed up to 3 years following completion of TNT]
- Overall survival [Time frame: Time between the date of signed consent to the date of death from any cause, assessed up to 3 years following completion of TNT]
Eligibility criteria
Inclusion criteria
- Participant must provide written informed consent before any study-specific procedures or interventions are performed
- Participants aged >= 18 years
- Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum:
- T3N0M0 - T4bN2M0
Exclusion criteria
- Has radiologic evidence of distant metastases at the time of screening/enrollment
- Has received prior treatment for their rectal adenocarcinoma
- Requires or has received blood transfusion within 1 month of study enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- OHSU Knight Cancer Institute — Portland
- Fred Hutch — Seattle
Identifiers
NCT: NCT05081024 · STUDY00022247 · NCI-2021-08733 · STUDY00022247