Clinical trial · Observational
High Definition Single Cell Analysis in Colorectal Cancer
- 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 research clinical trial studies high definition single cell analysis in blood and tissue samples from patients with colorectal cancer which has spread to the liver. High definition single cell analysis allows doctors to study the properties of cancer cells that are sometimes found in the blood of patients and to determine how the genes and proteins in them may change over time. Studying samples from patients with colorectal cancer in the laboratory may help doctors learn more about how cancer spreads, as well as how to predict the disease outcomes in patients with cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Carcinoma in the Liver | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Stage IV Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Analysis | Other | — | UNRESOLVED |
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (blood and tumor tissue collection)
- description
- Patients undergo collection of blood collection 1 week prior surgery, before and after surgery on the same day, and 1 week and 3 months after surgery. Patients also undergo and tissue collection during the surgery. Blood and tissue samples are processed for high definition single cell analysis including, whole-genome CNV profiles, protein expression, and cell morphology.
- interventionNames
- Other: Biomarker Analysis
- Other: Cytology Specimen Collection Procedure
Primary outcomes (2)
- measure
- HD-SCA liquid biopsy biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
- timeFrame
- Up to 2 years
- description
- Biosignatures will be compared between cells from tumor tissue within the same patient, cells from blood samples within the same patient, cells from tumor tissue and blood samples within the same patient, cells from tumor tissue and blood samples across different patients. Upon these comparisons, biosignatures will be established which represent liquid and solid biopsy correlations for each patient and for the patient population. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and acr
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent * Metastatic colorectal adenocarcinoma to the liver (hepatic mCRC) * Synchronous or metachronous * Solitary or multifocal * Concurrent abdominal lymph node metastasis is allowable * Hepatic mCRC deemed surgically resectable by the study team with plans to undergo surgery * Has not received any systemic chemotherapy for at least 21 days prior to scheduled hepatic resection Exclusion Criteria: * Non-adenocarcinoma metastatic colorectal cancer (e.g. neuroendocrine carcinoma); mucinous component is permitted * Metastatic CRC that involves organ(s)/tissue(s) other than abdominal lymph nodes and/or liver * Has received any systemic chemotherapy within 21 days prior to scheduled hepatic resection
References
Publications (0)
Data not yet available