Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer

Active, not recruiting

• Conditions: Locally Advanced Rectal Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Rectosigmoid Adenocarcinoma; Recurrent Rectal Adenocarcinoma; Recurrent Rectosigmoid Carcinoma; Stage III Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8
• Interventions: Procedure: Biospecimen Collection

• Registration Number: NCT02874885
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To establish the rate of circulating tumor elements (CTE), including but not limited to circulating tumor cells and circulating tumor deoxyribonucleic acid (DNA) detection in patients with locally advanced rectal cancer (LARC), relative to other stages.

II. To assess changes in detected CTEs associated with neoadjuvant therapy in patients with LARC.

III. To correlate CTEs with neoadjuvant treatment response as an indicator of disease risk.

OUTLINE:

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.

Study Timeline

• Study Start: 2013-09-05
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 341

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (biospecimen collection)	Biospecimen Collection	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.

Primary Outcome Measures

Name	Time	Method
Change in circulating tumor cells status	Baseline and 8 weeks after completion of treatment	A McNemar's test will be used to test whether neoadjuvant therapy (NEO) provided any improvement in the proportion of patients with any CTC. The CTC counts at baseline versus 8 weeks after completion of treatment will be compared with a paired t-test.
Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC)	Baseline up to 6 years	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States