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NCT02874885 Clinical Trial

Circulating Tumor Cells in Patients With Locally Advanced Rectal Cancer

Stage III Rectal Cancer AJCC v8 Clinical Trial

Official title:
Circulating Tumor Elements in Patients With Rectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02874885
Other study ID # PA13-0547
Secondary ID NCI-2020-07460PA
Status Active, not recruiting
Phase
First received
Last updated
Start date September 5, 2013
Est. completion date April 30, 2025

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 341
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood sample

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of treatment naive locally advanced rectal cancer (LARC) patients with circulating tumor cells (CTC) 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. Baseline up to 6 years
Primary Change in circulating tumor cells status 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. Baseline and 8 weeks after completion of treatment
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