Clinical trial · Observational
Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers
A Pilot Study of Monitoring Metastatic Colorectal Cancers With Liquid Biopsies
NCT03563651CI-TRIAL-00055099completedClinicalTrials.gov clinicaltrialsProvenance
- 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 trial studies the monitoring of therapy and progression by collecting blood, urine, and stool from participants with colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Studying samples of blood, urine, and stool from participants with colorectal cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIA Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIIB Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIIC Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage III Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IVA Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IVB Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IVC Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IV Colorectal Cancer AJCC v8 | Malignant Colorectal Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (biospecimen collection, biopsy)
- description
- Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression.
- interventionNames
- Procedure: Biopsy
- Procedure: Biospecimen Collection
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Detection rates of Kras, Braf, or PI3K tumor deoxyribonucleic acid (DNA) extracted from urine in patients with pre-existing mutations
- timeFrame
- Up to 5 years
- description
- Mutation detection rate will be estimated by gene and treatment cycle in each cohort. The quantities of mutated Kras, Braf, or PI3K will be estimated using means and standard deviation if the distribution of the quantities is compatible with normal distribution. Otherwise, medians, ranges and interquartiles will be used. The changes in the mutation status and quantities of Kras, Braf, and PI3K before and after starting the first line therapy will be estimated using contingency tables and plots.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy; the participating investigator will select treatment, however, patients with Kras wild type must receive anti-EGFR therapy to be eligible for this study * Subject consent to enrollment on the protocol * Histologically confirmed metastatic or un-resectable colorectal cancer, known Kras status; knowledge of other mutations is optional * Willingness to undergo biopsy at the time of progression * Willingness to follow the study instructions for collection of specimens * Available archival tissue
References
Publications (0)
Data not yet available
No reference posted for this study.