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

Colorectal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04739072
• Other study ID #: PA18-1171
• Secondary ID: NCI-2020-10034PA
• Status: Recruiting
• Start date: November 22, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Arvind Dasari
• Phone: (713) 792-2828
• Email: adasari[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Adenocarcinoma
• Colorectal Neoplasms
• Neoplasm, Residual
• 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
• Stage IV Colorectal Cancer AJCC v6
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and tissue samples

Other:
• Electronic Health Record Review
Review of medical records

Locations

Country	Name	City	State
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	Banner - MD Anderson Cancer Center	Gilbert	Arizona
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Houston Methodist Cancer Center	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	Baptist- MD Anderson Cancer Center	Jacksonville	Florida
United States	UT Health San Antonio MD Anderson Cancer Center	San Antonio	Texas
United States	Baylor Scott & White Research Institute	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences		Up to 5 years
Other	Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences		Up to 5 years
Other	Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS		Up to 5 years
Other	Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations		Up to 5 years
Primary	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
Primary	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	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
Secondary	Disease free survival (DFS)		Up to 5 years
Secondary	Overall survival (OS)		Up to 5 years

External Links

•   M D Anderson Cancer Center