Clinical trial NCT04739072: Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
Official title: Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)
Study type: OBSERVATIONAL
Overall status: 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
Stage IV Colorectal Cancer AJCC v6
Stage IVA Colorectal Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer at MD 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma
timeFrame: Up to 5 years
measure: Detection of recurrences post completion of curative therapies
timeFrame: Up to 5 years
Secondary outcomes:
measure: Changes in cancer-specific plasma alterations during neoadjuvant, adjuvant therapies and surveillance
timeFrame: Baseline up to 5 years
measure: Disease free survival (DFS)
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
Other outcomes:
measure: Optimal combination of cancer-specific plasma DNA, RNA and / or proteomic alterations for early detection of recurrences
timeFrame: Up to 5 years
measure: Sensitivity, specificity, positive predictive and negative predictive values of cancer-specific plasma alterations in detecting recurrences
timeFrame: Up to 5 years
measure: Correlation between cancer-specific alterations in plasma and tissue and either with outcomes including DFS & OS
timeFrame: Up to 5 years
measure: Nature and frequency of detection of incidental non-colorectal cancer related DNA, RNA and / or proteomic alterations
timeFrame: Up to 5 years
Locations:
city: Gilbert
country: United States
facility: Banner - MD Anderson Cancer Center
state: Arizona
city: Jacksonville
country: United States
facility: Baptist- MD Anderson Cancer Center
state: Florida
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Boise
country: United States
facility: St. Luke's Cancer Institute
state: Idaho
city: Camden
country: United States
facility: Cooper Hospital UNIV MED CTR.
state: New Jersey
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio MD Anderson Cancer Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Arvind Dasari
role: PRINCIPAL_INVESTIGATOR
References: