Predicting the Efficacy and Prognosis of Rectal Cancer Patients Based on ctDNA-MRD Technology

July 31, 2023 updated by: WeiWei Xiao

Predicting the Efficacy and Prognosis of Rectal Cancer Patients Receiving Neoadjuvant Chemoradiotherapy Based on Circulating Tumor DNA-minimal Residual Disease Technology : A Prospective, Observational Study

The purpose of this study is to study the performance of MRD monitoring in predicting the efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore the value of MRD detection in evaluating the prognosis of patients. In this prospective study, 50 patients with stage II-III rectal cancer who are planing to receive neoadjuvant chemoradiotherapy will be enrolled. The tumor tissue will be collected by colonoscopy before treatment and blood samples will be collected before treatment and during treatment.The whole blood samples will receive MRD detection. The change rate and clearance rate of MRD during treatment will be calculated, and will be associated with imaging efficacy evaluation, pathological efficacy evaluation,and prognosis, to determine the performance of MRD in predicting and judging the efficacy of neoadjuvant chemoradiotherapy and postoperative recurrence of rectal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, observational study. It is expected to enroll 50 patients with newly diagnosed stage II-III rectal cancer.Before neoadjuvant chemoradiotherapy, tumor tissue will be collected by colonoscopy biopsy for WES and customized panel design, and peripheral blood samples will be collected for baseline MRD detection ( MRD1 ) and during neoadjuvant concurrent chemoradiotherapy ( MRD2-6 ) .Peripheral blood sample will be collected 3-4 weeks after radical surgery ( MRD7 ). For patients who achieved cCR after the end of neoadjuvant therapy and adopted the W & W ( watch and wait ) strategy, the sampling time point was 3 months after the start of watching and waiting ( MRD7 ).

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • WeiWei Xiao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study intends to include 50 patients with stage II-III rectal cancer who plan to receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old.

Description

Inclusion Criteria:

  1. Age 18-75
  2. Rectal adenocarcinoma confirmed by pathology
  3. The clinical stage is II-III.
  4. Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose to wait for observation ).
  5. ECOG 0-1;
  6. No distant metastasis ;
  7. Main organ function is normal ;
  8. signed informed consent and willing to accept long-term follow-up；
  9. No anti-tumor treatment was received within 4 weeks before baseline sampling ;

  10. Adequate ' colonoscopy ' tumor tissue samples can be provided for MRD customization, and sufficient whole blood samples need to be provided for baseline MRD detection.

    -

Exclusion Criteria:

  1. unable to provide sufficient tissue / blood samples to meet the research needs ;
  2. received radiotherapy, chemotherapy, or other targeted or immunotherapy before enrollment ;
  3. Patients did not receive neoadjuvant therapy according to the original plan ;
  4. Patients refused to accept genetic testing. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
A total of 50 patients with stage II-III rectal cancer who plan to receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old, and these patients have no distant metastasis, normal main organ function, and can receive long-term follow-up. simultaneously, these patients are required to provide sufficient ' colonoscopy collection ' tumor tissue samples for MRD customization, and sufficient whole blood samples are required for baseline MRD detection.
Diagnostic test: MRD detection
Peripheral blood samples were collected for MRD detection before neoadjuvant chemoradiotherapy, during neoadjuvant chemoradiotherapy, and 3-4 weeks after radical surgery. For patients who achieved cCR after neoadjuvant therapy and adopted the W & W strategy, the sampling time point was 3 months after the start of watching and waiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the ROC curve (AUC) of the MRD biomarker
Time Frame: Baseline to 12 months
The area under the ROC curve ( AUC ) of MRD
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence-free survival（LRFS）
Time Frame: From date of radical surgery to local recurrence or death due to disease progression，assessed up to 60 months.
LRFS differences in patients with MRD clearance / decrease / increase
From date of radical surgery to local recurrence or death due to disease progression，assessed up to 60 months.
Distant metastases-free survival（DMFS）
Time Frame: From date of the beginning of neoadjuvant chemoradiotherapy to disease metastasis or death due to any cause,assessed up to 60 months.
DMFS differences in patients with MRD clearance / decrease / increase
From date of the beginning of neoadjuvant chemoradiotherapy to disease metastasis or death due to any cause,assessed up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WeiWei Xiao

Collaborators

Haplox Biotechnology Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2023-239-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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