Rectal Cancer PatientsNCT07112937
The Effect of Multimodal Treatment of Rectal Cancer on Circulating Tumor Cells: A Prospective, Observational Study
An observational study of Rectal Cancer Patients, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Patients
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 2 May 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rectal cancer patients
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava
Peter Ihnat, Profesor, MD, PhD., 420 597 375 701, peter.ihnat@fno.cz
About this study
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
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer patients with neoadjuvant chemoradiotherapy | Not described | |
| Rectal cancer patients without neoadjuvant chemoradiotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of circulating tumor cells in peripheral blood
The levels of circulating tumor cells will be measured in rectal cancer patients
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start2 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112937
- Sponsor's protocol ID
- 01/RVO-FNOs/2023
- Other IDs
- LF_2023_0118
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients code; sex; age; diagnosis; clinical, laboratory and experimental findings
Publications
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.
PubMed 38302423
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multimodal Treatment of Rectal Cancer on Circulating Tumor Cells: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07112937
- Acronym / sponsor ID
- 01/RVO-FNOs/2023
- Conditions
- Rectal Cancer Patients
- Keywords
- circulating tumor cells
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer patients with neoadjuvant chemoradiotherapy | – | – |
| Rectal cancer patients without neoadjuvant chemoradiotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of circulating tumor cells in peripheral blood
Time frame: 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.
The levels of circulating tumor cells will be measured in rectal cancer patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 38302423Ihnat 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.
- Individual participant dataSharing planned: Yes. Patients code; sex; age; diagnosis; clinical, laboratory and experimental findings
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer Patients, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josef Srovnal, Associate professor, MD, PhD (+420 585632137, josef.srovnal@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of circulating tumor cells in peripheral blood (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07112937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.