Rectal AdenocarcinomaNCT05081024
Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
An observational study of Rectal Adenocarcinoma and Stage II Rectal Cancer AJCC v8, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8
- What is being tested?
- Biopsy, Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2021to 3 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage II-III rectal adenocarcinoma at Oregon Health \& Science University (OHSU), its affiliated community oncology (CHO) site, or collaborating research site
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Adel Kardosh, M.D.,Ph.D., 503-494-5207, kardosh@ohsu.edu
Adel Kardosh, M.D.,Ph.D.
- Recruiting
Fred Hutch
Seattle, Washington, 98109
Stacey Cohen, MD, 206.606.6658, shiovitz@uw.edu
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the percentage of participants that achieve complete clinical response.
SECONDARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
- Being tested
- Biopsy, Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo collection of blood and/or tissue samples
Electronic Health Record ReviewOther
Medical records are reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection, medical record review) | 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. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months.
Secondary outcomes (7)
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.
Measured: 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
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.
Measured: 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
Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented.
Measured: Up to 3 years following completion of TNT
Rate of pathological complete response (pCR)
Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented.
Measured: From start of treatment until completion of surgery, up to 3 years.
Rate of watch and wait strategy
Will be evaluated using the TNT analysis set. The corresponding exact 95% CI will also be presented.
Measured: Up to 3 years following completion of TNT
Disease-free survival
Will be estimated using the Kaplan-Meier method.
Measured: 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
Will be estimated using the Kaplan-Meier method.
Measured: Time between the date of signed consent to the date of death from any cause, assessed up to 3 years following completion of TNT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start3 Sep 2021
- Primary completion3 Sep 2027 (estimated)
- Study completion3 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc.
- Responsible party
- Principal investigator, Adel Kardosh M.D., Ph.D., OHSU Knight Cancer Institute
- Investigators
- Adel Kardosh, M.D.,Ph.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081024
- Sponsor's protocol ID
- STUDY00022247
- Other IDs
- NCI-2021-08733, STUDY00022247
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2021
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No