Minimal Residual Disease Assessment in Patients with Colorectal Cancer, the MiRDA-C Study

Recruiting

• Conditions: Colorectal Adenocarcinoma; Stage I Colorectal Cancer AJCC V8; Stage II Colorectal Cancer AJCC V8; Stage IIA Colorectal Cancer AJCC V8; Stage IIB Colorectal Cancer AJCC V8; Stage IIC Colorectal Cancer AJCC V8; Stage III Colorectal Cancer AJCC V8; Stage IIIA Colorectal Cancer AJCC V8; Stage IIIB Colorectal Cancer AJCC V8; Stage IIIC Colorectal Cancer AJCC V8
• Interventions: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

• Registration Number: NCT04739072
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread.

Detailed Description

PRIMARY OBJECTIVES:

I. Demonstrate ability to monitor cancer-specific deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma.

II. Improve detection of recurrences post completion of curative therapies through monitoring of plasma cancer-specific DNA, RNA and proteomic alterations.

SECONDARY OBJECTIVES:

I. Qualitative and quantitative changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance.

II. Disease free survival (DFS) of patients with detectable cancer-specific plasma alterations.

III. Overall survival (OS) of patients with detectable cancer-specific plasma alterations.

EXPLORATORY OBJECTIVES:

I. Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences.

II. Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences.

III. Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS \& OS.

IV. Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations.

OUTLINE:

Patients undergo collection of blood samples at baseline, during each neoadjuvant therapy treatment, prior to surgical resection, and up to 4 times per year for up to 5 years. Patients also undergo collection of tissue sample at time of surgical resection. Patients' medical records may also be reviewed.

Study Timeline

• Study Start: 2019-11-22
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Age ≥ 18 years.
2. Histological/cytological confirmation of colorectal adenocarcinoma.
3. Patients with any stage colorectal adenocarcinoma deemed potentially eligible for curative intent treatment. Patients with stages II-IV colorectal cancer post-R0 resection may also be enrolled onto the protocol any time before or up to 3 months post-surgery and prior to initiating adjuvant therapy.
4. Ability to understand and the willingness to sign a written informed consent document.
5. Willing to pursue standard of care surveillance post completion of curative therapies.
6. Willing to provide blood samples for correlative research.

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Exclusion Criteria

1. Known active malignancies other than colorectal adenocarcinoma that may interfere with detection and / or interpretation of circulating plasma markers. Patients with known clonal hematopoiesis of indeterminate potential are eligible.
2. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (biospecimen collection)	Biospecimen Collection	Patients undergo collection of blood samples at baseline, during each neoadjuvant therapy treatment, prior to surgical resection, and up to 4 times per year for up to 5 years. Patients also undergo collection of tissue sample at time of surgical resection. Patients medical records may also be reviewed.
Ancillary-correlative (biospecimen collection)	Electronic Health Record Review	Patients undergo collection of blood samples at baseline, during each neoadjuvant therapy treatment, prior to surgical resection, and up to 4 times per year for up to 5 years. Patients also undergo collection of tissue sample at time of surgical resection. Patients medical records may also be reviewed.

Primary Outcome Measures

Name	Time	Method
Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma	Up to 5 years	To detect circulating tumor DNA (ctDNA) in plasma samples from patients with colorectal cancer (CRC) who have completed curative therapies (i.e. minimal residual disease) towards predicting recurrence earlier than the current standard of care utilizing the CRC23 assay and the LUNAR assay from Guardant Health technology.
Detection of recurrences post completion of curative therapies	Up to 5 years	To detect ctDNA in plasma samples from patients with CRC who have completed curative therapies (i.e. minimal residual disease) towards predicting recurrence earlier than the current standard of care utilizing the CRC23 assay and the LUNAR assay from Guardant Health technology.

Secondary Outcome Measures

Name	Time	Method
Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance	Baseline up to 5 years	Will assess the association between changes in circulating molecules and response in patients undergoing neoadjuvant therapy by linear or logistic regression models
Disease free survival (DFS)	Up to 5 years
Overall survival (OS)	Up to 5 years

Trial Locations

Locations (10)

Banner - MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Baptist- MD Anderson Cancer Center; 🇺🇸 Jacksonville, Florida, United States

The Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

St. Luke's Cancer Institute; 🇺🇸 Boise, Idaho, United States

Cooper Hospital UNIV MED CTR.; 🇺🇸 Camden, New Jersey, United States

UT Southwestern/Simmons Cancer Center-Dallas; 🇺🇸 Dallas, Texas, United States

Houston Methodist Cancer Center; 🇺🇸 Houston, Texas, United States

UT Health San Antonio MD Anderson Cancer Center; 🇺🇸 San Antonio, Texas, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Baylor Scott & White Research Institute; 🇺🇸 Temple, Texas, United States