Clinical trial · Observational
Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer
Circulating Tumor Elements in Patients With Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
This study looks at the level of circulating tumor elements (cancer cells or DNA pieces floating in the blood) and how it may be related to how the tumor responds to standard treatment in patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Researchers will also compare the level and genetic characteristics of circulating tumor elements between individuals with rectal cancer and healthy individuals to understand how they may change over time. Information from this study may help researchers better understand rectal cancer.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Adenocarcinoma | Rectal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Rectal Adenocarcinoma | Rectal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Rectosigmoid Adenocarcinoma | Rectosigmoid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Rectal Adenocarcinoma | Rectal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Recurrent Rectosigmoid Carcinoma | Rectosigmoid Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (biospecimen collection)
- description
- Patients and healthy participants undergo collection of blood sample at baseline. Patients may also undergo collection of blood sample collections during tumor surgery, 4 weeks after surgery or after completion of treatment if you are not surgery, 8 weeks after the last dose of chemotherapy, 1 year after surgery or 1 year after completion of treatment if not having surgery, 2 years after surgery or 2 years after completion of treatment if not having surgery, and within 6 years after treatment or at the end of the 6 year follow-up if the disease gets worse with treatment or comes back.
- interventionNames
- Procedure: Biospecimen Collection
Primary outcomes (2)
- measure
- Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)
- timeFrame
- Baseline up to 6 years
- description
- The proportion of patients with any CTC will be calculated with a 95% confidence interval (CI). Additionally, the actual CTC count will be plotted with a box-plot. Proportions of patients with 2 or more, and 3 or more CTCs will be calculated. Will also explore correlations between the presence of 1 or more CTC and primary tumor characteristics using Chi-Squared or Fischer's exact tests as appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HEALTHY SUBJECT: No known diagnosis of colorectal cancer (CRC) or any other type of cancer for the last 10 years.(basal cell skin cancer is allowed). Subjects will be asked about their cancer history and a verbal confirmation is required * Any patient with diagnosis of rectal (or rectosigmoid) adenocarcinoma, including: * Patients with primary disease with or without neoadjuvant therapy; OR * Patients with recurrent disease with or without neoadjuvant therapy; OR * Patients with metastatic disease with or without prior treatment * No known current diagnosis of other invasive cancer; if prior diagnosis of other cancer, he/she has been free from cancer for \>= 3 years and is on no active treatment * Adequate mental and language capacity to provide consent
References
Publications (0)
Data not yet available