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

Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Adenocarcinoma; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC 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; 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 IV Colorectal Cancer AJCC v6
• Intervention / Treatment: Other: Electronic Health Record Review; Procedure: Biospecimen Collection

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Arvind Dasari; Phone Number: (713) 792-2828; Email: adasari@mdanderson.org

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Recruiting
      • Banner - MD Anderson Cancer Center
      • Contact: Tomislav Dragovich, MD; Phone Number: 480-256-6444; Email: Tomislav.Dragovich@bannerhealth.com
      • Principal Investigator: Tomislav Dragovich, MD
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist- MD Anderson Cancer Center
      • Contact: Robert Zaiden, MD; Phone Number: 904-202-7300; Email: robert.zrobert.zaiden@bmcjax.com
      • Principal Investigator: Robert Zaiden, MD
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Recruiting
      • The Queen's Medical Center
      • Contact: Jared Acoba, MD; Phone Number: 808-531-8521; Email: jacoba@hawaii.edu
      • Principal Investigator: Jared Acoba, MD
  • Idaho
    • Boise, Idaho, United States, 83712
      • Recruiting
      • St. Luke's Cancer Institute
      • Contact: Dan Zuckerman, MD; Phone Number: 208-381-2711; Email: zuckermd@slhs.org
      • Principal Investigator: Dan Zuckerman, MD
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper Hospital UNIV MED CTR.
      • Contact: Jamin Morrison, MD; Phone Number: 855-632-2667; Email: morrison-jamin@CooperHealth.edu
      • Principal Investigator: Jamin Morrison, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern/Simmons Cancer Center-Dallas
      • Contact: Syed Kazmi, MD; Phone Number: 214-645-4673; Email: syed.kazmi@utsouthwestern.edu
      • Principal Investigator: Syed Kazmi, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Arvind Dasari; Phone Number: 713-792-2828; Email: adasari@mdanderson.org
      • Principal Investigator: Arvind Dasari
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Cancer Center
      • Contact: Maen Abdelrahim, MD, PhD; Phone Number: 713-606-2418; Email: mabdelrahim@houstonmethodist.org
      • Principal Investigator: Maen Abdelrahim, MD, PhD
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • UT Health San Antonio MD Anderson Cancer Center
      • Contact: Shruti Pandita, MD; Phone Number: 210-567-4774; Email: dita@uthscsa.edu
      • Principal Investigator: Shruti Pandita, MD
    • Temple, Texas, United States, 76508
      • Terminated
      • Baylor Scott & White Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer at MD Anderson Cancer Center.

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-correlative (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.	Other: Electronic Health Record Review; Review of medical records; Procedure: Biospecimen Collection; Undergo collection of blood and tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma	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.	Up to 5 years
Detection of recurrences post completion of curative therapies	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.	Up to 5 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences	Up to 5 years
Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences	Up to 5 years
Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS	Up to 5 years
Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations	Up to 5 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Arvind Dasari, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm, Residual
• Other Study ID Numbers: PA18-1171 (Other Identifier: M D Anderson Cancer Center); NCI-2020-10034 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No