Clinical trial · Observational
Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
Minimal Residual Disease Assessment in Colorectal Cancer (MiRDA-C)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage I Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIA Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIB Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIC Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage II Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIIA Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIIB Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-correlative (biospecimen collection)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
Primary outcomes (2)
- measure
- Analysis of deoxyribonucleic (DNA), ribonucleic acid (RNA), and proteomic alterations from plasma
- timeFrame
- Up to 5 years
- description
- 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.
- measure
- Detection of recurrences post completion of curative therapies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available