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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05969938
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Collaborator:
Haplox Biotechnology Co., Ltd.
Information provided by (Responsible Party):
WeiWei Xiao, Sun Yat-sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Rectal Adenocarcinoma Circulating Tumor DNA Minimal Residual Disease Neoadjuvant Chemoradiotherapy Diagnostic Test: MRD detection

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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 21, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : August 31, 2024
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
The samples including two kinds :1.We will collect tumor tissue samples for WES detection and customized panel.2. We will collect peripheral blood samples for MRD detection.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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. -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05969938


Contacts
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Contact: WeiWei Xiao 8613710390520 ext 8613710390520 xiaoww@sysucc.org.cn

Locations
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China, Guangdong
WeiWei Xiao Recruiting
Guangzhou, Guangdong, China, 510060
Contact: WeiWei Xiao    +8613710390520    xiaoww@sysucc.org.cn   
Sponsors and Collaborators
WeiWei Xiao
Haplox Biotechnology Co., Ltd.
More Information
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Publications:

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Responsible Party: WeiWei Xiao, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05969938    
Other Study ID Numbers: B2023-239-01
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm, Residual
Neoplasms
Neoplastic Processes
Pathologic Processes