The Effect of Multimodal Treatment of Rectal Cancer on Circulating Tumor Cells: A Prospective, Observational Study

NCT07112937 | Recruiting

• 2 other identifiers: 01/RVO-FNOs/2023LF_2023_0118
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The prospective study will focus on patients undergoing multimodal treatment for rectal cancer. The main objective of the study will be to monitor changes in circulating tumor cells (CTCs) in the peripheral blood of patients during multimodal treatment. For each patient enrolled in the study, peripheral blood samples will be collected at specified time intervals to determine the presence and quantity of CTCs. The CTCs levels will be compared among rectal cancer patients with neoadjuvant chemoradiotherapy and without neoadjuvant chemotherapy.

Conditions

Rectal Cancer Patients

Keywords

circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• Levels of circulating tumor cells in peripheral blood

  The levels of circulating tumor cells will be measured in rectal cancer patients

  The levels of circulating tumor cells will be measured in 5 time points: before neoadjuvant chemoradiotherapy, in 3. week of chemoradioterapy, before surgery, one week after surgery and one month after surgery.

Study Arms (2)

Rectal cancer patients with neoadjuvant chemoradiotherapy

Rectal cancer patients without neoadjuvant chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rectal cancer patients

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Czechia

RECRUITING

Related Publications (1)

• Ihnat P, Srovnal J, Hrubovcak J, Martinek L. Detection and clinical significance of circulating tumour cells in patients with colorectal carcinoma. Rozhl Chir. 2023;102(10):376-380. doi: 10.33699/PIS.2023.102.10.376-380.

  PMID: 38302423 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Josef Srovnal, Associate professor, MD, PhD

CONTACT

+420 585632137; josef.srovnal@upol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: May 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CZ (1)