Clinical trial · Observational
Immunoscore in Rectal Cancer
A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy
NCT02017509CI-TRIAL-00034633completedClinicalTrials.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 is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
| Neoplasms, Rectal | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Tumors | Rectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Biopsy and Surgical Procedure | Procedure | — | UNRESOLVED |
| Dynamic Contrast Enhanced MRI (DCE-MRI) | Procedure | — | UNRESOLVED |
| Intravoxel incoherent motion MRI (IVIM) | Procedure | — | UNRESOLVED |
| RNA gene expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Rectal Cancer Patients
- description
- Patients with a diagnosis adenocarcinoma of the rectum will provide a tumor sample from their diagnostic biopsy and surgical procedure for research purposes, including RNA gene expression analysis. In addition to a standard MRI, patients will have an Intravoxel Incoherent Motion MRI (IVIM) and a Dynamic Contrast Enhanced MRI (DCE-MRI) for research purposes.
- interventionNames
- Procedure: Diagnostic Biopsy and Surgical Procedure
- Procedure: Intravoxel incoherent motion MRI (IVIM)
- Procedure: Dynamic Contrast Enhanced MRI (DCE-MRI)
- Genetic: RNA gene expression analysis
Primary outcomes (1)
- measure
- Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response
- timeFrame
- 16 weeks
- description
- Quantitative immunohistochemical analysis will be performed on parameters of interest on both pre-treatment biopsy specimens as well as post-operative specimens. The pre-treatment sample will be used to establish the immunophenotype score. The primary analysis will evaluate the ability of immunophenotype score to correlate with pathologic response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum. * Age \> 18 * Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. Exclusion Criteria: * History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer * Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.