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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 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.

Clinical Trial 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 Design

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
Clinical Trial Details
NCT number NCT04739072
Study type Observational
Source M.D. Anderson Cancer Center
Contact Arvind Dasari
Phone (713) 792-2828
Email adasari@mdanderson.org
Status Recruiting
Phase
Start date November 22, 2019
Completion date December 31, 2025
View Details
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