Clinical trial · Observational
Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
Longitudinal Enumeration of Circulating Tumor Cells in Patients With Metastatic Colorectal Carcinomas
- 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 enrolled patients with measurable metastatic colorectal cancer. Blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (\~every 6 to 12 weeks). The blood was tested to find circulating tumor cells (CTCs) and to count them. The CTC levels were compared to the imaging study results to see if the CTC number and the imaging result (progression/no progression) were in agreement. Maximum active study participation was 12 months with up to 8 blood draws being taken. All patients are currently being followed for up to 24 months from their off study date for survival. The CTC result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of CTCs.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Neoplasm Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phlebotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- description
- Patients with measurable metastatic colorectal cancer about to start a new line of chemotherapy.
- interventionNames
- Procedure: Phlebotomy
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Measurable metastatic carcinoma of the colon or rectum. * 1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor \[EGFR\] targeted therapy) * Chest/abdomen/pelvis scans every 6-12 weeks * ECOG 0-2 * Hemoglobin (Hgb) \> or = 8g/dl within 7 days prior to enrollment * Age \> or = to 18 years of age Exclusion Criteria: * Cumulative weekly blood draws exceeding 150mL/week * Brain metastasis * Prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (DCIS), non-invasive cervical cancer or non-melanoma skin cancer * Surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device
References
Publications (2)
- BACKGROUNDCohen SJ, Alpaugh RK, Gross S, O'Hara SM, Smirnov DA, Terstappen LW, Allard WJ, Bilbee M, Cheng JD, Hoffman JP, Lewis NL, Pellegrino A, Rogatko A, Sigurdson E, Wang H, Watson JC, Weiner LM, Meropol NJ. Isolation and characterization of circulating tumor cells in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2006 Jul;6(2):125-32. doi: 10.3816/CCC.2006.n.029. PMID 16945168
- DERIVEDCoumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res. 2012 Oct 15;18(20):5711-8. doi: 10.1158/1078-0432.CCR-12-1585. Epub 2012 Sep 25. PMID 23014524