Clinical trial · Observational
Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer
NCT05115786CI-TRIAL-00064919unknownClinicalTrials.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)
A Retrospective Cohort Study to Evaluate a Multigene assay to assess the recurrence risk of colorectal cancer.
Conditions
Conditions (1)
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Cohort A
- description
- FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.
- label
- Cohort B
- description
- FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.
- label
- Cohort C
- description
- FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.
- label
- Cohort D
- description
- FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Cohort A Inclusion Criteria: * Subjects must be 20 years of age or older. * Subjects was diagnosed with anatomic stage II, T3, MMR-P colorectal cancer * Subjects had recurrence date information within 5 years follow-up after initial tumor resection surgery * Subject is able and willing to provide FFPE sample per protocol * Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: * No tumor block available from initial diagnosis before any chemotherapy treatment * Presence of synchronous tumors * No tumor or very little tumor (\<5% tumor present) in block as assessed designated pathologist. * Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by designated pathologist. * Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR analysis. * Failure of assay to meet pre-specified quality control (QC) specifications. Cohort B Inclusion Criteria: * Subjects must be 20 years of age or older. * Subjects was diagnosed with anatomic stage II, T3, MMR-P colorectal cancer * Subjects had 5 years follow-up information after initial tumor resection surgery * Subject is able and willing to provide FFPE sample per protocol * Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: * No tumor block available from initial diagnosis before any chemotherapy treatment * Presence of synchronous tumors * No tumor or very little tumor (\<5% tumor present) in block as assessed designated pathologist. * Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by designated pathologist. * Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR analysis. * Failure of assay to meet pre-specified quality control (QC) specifications. Cohort C Inclusion Criteria: * Subjects must be 20 years of age or older. * Subjects was diagnosed with anatomic stage III A/B colorectal cancer * Subjects had recurrence date information within 5 years follow-up after initial tumor resection surgery * Subject is able and willing to provide FFPE sample per protocol * Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: * No tumor block available from initial diagnosis before any chemotherapy treatment * Presence of synchronous tumors * No tumor or very little tumor (\<5% tumor present) in block as assessed designated pathologist. * Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by designated pathologist. * Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR analysis. * Failure of assay to meet pre-specified quality control (QC) specifications. Cohort D Inclusion Criteria: * Subjects must be 20 years of age or older. * Subjects was diagnosed with anatomic stage III A/B colorectal cancer * Subjects had 5 years follow-up information after initial tumor resection surgery * Subject is able and willing to provide FFPE sample per protocol * Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study Exclusion Criteria: * No tumor block available from initial diagnosis before any chemotherapy treatment * Presence of synchronous tumors * No tumor or very little tumor (\<5% tumor present) in block as assessed designated pathologist. * Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by designated pathologist. * Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR analysis. * Failure of assay to meet pre-specified quality control (QC) specifications.
References
Publications (0)
Data not yet available
No reference posted for this study.