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Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer

ConditionsRectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage IIA Rectal Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must provide written informed consent before any study-specific procedures or interventions are performed

Participants aged >= 18 years

T3N0M0 - T4bN2M0

Disqualifiers

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

Trial population

Patients with stage II-III rectal adenocarcinoma at Oregon Health \& Science University (OHSU), its affiliated community oncology (CHO) site, or collaborating research site

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and/or tissue samples

  • Electronic Health Record Review

    Other intervention

    Medical records are reviewed

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Observational (biospecimen collection, medical record review)3 interventions

Trial outcomes

Primary outcomes

1

Complete clinical response (cCR)

cCR following TNT will be analyzed using the TNT analysis set. Proportions of participants that achieved cCR will be calculated and the exact 95% confidence interval (CI) will be presented.

Time frame
From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months.

Secondary outcomes

1

Positive circulating tumor deoxyribonucleic acid (ctDNA)

The proportion of ctDNA positive participants (at baseline, throughout TNT, and follow-up) and its exact 95% CI will be evaluated using the ctDNA analysis set. Where appropriate, sub-analyses will be conducted using populations that underwent surgery or were monitored using a watch and wait (W\&W) strategy.

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.
2

Positive ctDNA after completing TNT

The proportion of ctDNA positive participants (at baseline, throughout TNT, and follow-up) and its exact 95% CI will be evaluated using the ctDNA analysis set. Where appropriate, sub-analyses will be conducted using populations that underwent surgery or were monitored using a W\&W strategy.

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
3

Rate of transabdominal surgery

Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented.

Time frame
Up to 3 years following completion of TNT
4

Rate of pathological complete response (pCR)

Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented.

Time frame
From start of treatment until completion of surgery, up to 3 years.

Other outcomes

1

ctDNA status

positive versus negative results per test results

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
2

Positive ctDNA by clinical characteristics

association or recurrence on ctDNA test and standard imaging

Time frame
From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT
3

Sensitivity

Sensitivity and specificity will be calculated using complete clinical response (yes versus \[vs.\] no), or tumor recurrence (yes vs. no) as reference standard.

Time frame
From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT
4

Specificity

Sensitivity and specificity will be calculated using complete clinical response (yes vs. no), or tumor recurrence (yes vs. no) as reference standard.

Time frame
From date of baseline measure of ctDNA to date of recurrence or death from any cause, assessed up to 3 years following completion of TNT

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Natera, Inc.

Collaborator

Source ClinicalTrials.gov
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