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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04739072
Collaborator
(none)
1,000
9
73.3
111.1
1.5

Study Details

Study Description

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

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

SECONDARY OBJECTIVES:
  1. Qualitative and quantitative changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance.

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

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

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

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

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

  4. 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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)
Actual Study Start Date :
Nov 22, 2019
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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.

Procedure: Biospecimen Collection
Undergo collection of blood and tissue samples

Other: Electronic Health Record Review
Review of medical records

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

  2. Disease free survival (DFS) [Up to 5 years]

  3. Overall survival (OS) [Up to 5 years]

Other Outcome Measures

  1. Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences [Up to 5 years]

  2. Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences [Up to 5 years]

  3. Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS [Up to 5 years]

  4. Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner - MD Anderson Cancer Center Gilbert Arizona United States 85234
2 Baptist- MD Anderson Cancer Center Jacksonville Florida United States 32207
3 The Queen's Medical Center Honolulu Hawaii United States 96813
4 St. Luke's Cancer Institute Boise Idaho United States 83712
5 Cooper Hospital UNIV MED CTR. Camden New Jersey United States 08103
6 Houston Methodist Cancer Center Houston Texas United States 77030
7 M D Anderson Cancer Center Houston Texas United States 77030
8 UT Health San Antonio MD Anderson Cancer Center San Antonio Texas United States 78229
9 Baylor Scott & White Research Institute Temple Texas United States 76508

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT04739072
Other Study ID Numbers:
  • PA18-1171
  • NCI-2020-10034
  • PA18-1171
First Posted:
Feb 4, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022