Cervical Cancer Stage IA1CTC-COLNCT04770090
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
A study testing Blood samples in people with Cervical Cancer Stage IA1 and Cervical Cancer Stage IB1, run by University Hospital, Montpellier at 3 sites in France.
Trial summary
Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Mar 2022to 5 Dec 2027
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman >18 years old
- Cervical cancer confirmed by histology
- Early stage eligible for immediate surgical treatment (or post-brachytherapy): stages IA1, 1A2, 1B1 and IB2 with or without emboli determined by MRI performed as part of the treatment
- Histology : epidermoid carcinoma and adenocarcinoma
- Valid Social Security
- Wrote consent
Who cannot join
- Advanced stage (Stage IB3 and more)
- Concomitant cancer
- Pregnant or breastfeeding woman
- Vulnerable person (Article L1121-6 of the Public Health Code)
- Participation to other study with an exclusion period still in progress
- Participation to other study that may have an impact on the prognosis of cervical cancer
Trial locations and contacts
3 sites in 1 country.
France3 sites
Department of gynaecology, Montpellier University Hospital
Montpellier, 34295
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298
CHU de Nîmes
Nîmes
About this study
Official title: Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery.
The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.
The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.
20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.
Read the detailed description
CTC detection could be a pronostic factor for cancer evolution. Cervical cancer is a rare pathology with increased death rate.
Despite recommendations for coelioscopic treatment of < 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery.
Hypothesis : Mobilization of the tumor during coelioscopy leads to CTC spread. This spread could explain the recurrence of cervical cancer.
This pilot study will evaluate the possibility of CTC detection during surgery. The primary goal is to evaluate the spread of CTC during the different steps of surgery on peripheral blood samples.
The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.
20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.
- Conditions
- Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2, Cervical Cancer Stage IB2
- Being tested
- Blood samples
- Keywords
- Cervical cancer, Circulating tumor cell, Coelioscopy, Disease-free survival, Laparoscopy
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.
| Study group | Role | What they receive |
|---|---|---|
| Early stage cervical cancer | Experimental | Patients with cervical cancer eligible for surgery, stage IA1 to IB2 Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating tumor cell detected after cervical cancer surgery.
Detection of the presence of at least one circulating tumor cell from blood samples taken during surgery (one CTC per 7.5mL of blood or increase of at least one CTC if CTC is present pre-operatively)
Measured: Within 48 hours after surgery.
Secondary outcomes (1)
Evaluation of disease-free survival
The disease-free survival will be evaluated at 3 and 5 years post-operatively
Measured: Two points at the 3rd and 5th years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Mar 2022
- Primary completion5 Dec 2022
- Study completion5 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Stage IA1Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Institut du Cancer de Montpellier - Val d'Aurelle, Laboratoire Cellules Circulantes Rares Humaines
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770090
- Sponsor's protocol ID
- RECHMPL20_0090
- Acronym
- CTC-COL
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
- ClinicalTrials.gov ID
- NCT04770090
- Acronym / sponsor ID
- CTC-COL / RECHMPL20_0090
- Conditions
- Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2, Cervical Cancer Stage IB2
- Keywords
- Cervical cancer, Circulating tumor cell, Coelioscopy, Disease-free survival, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Institut du Cancer de Montpellier - Val d'Aurelle, Laboratoire Cellules Circulantes Rares Humaines
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2027 (estimated)
- First posted
- 25 Feb 2021 (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.
Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery.
The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.
The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.
20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.
Detailed description
CTC detection could be a pronostic factor for cancer evolution. Cervical cancer is a rare pathology with increased death rate.
Despite recommendations for coelioscopic treatment of < 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery.
Hypothesis : Mobilization of the tumor during coelioscopy leads to CTC spread. This spread could explain the recurrence of cervical cancer.
This pilot study will evaluate the possibility of CTC detection during surgery. The primary goal is to evaluate the spread of CTC during the different steps of surgery on peripheral blood samples.
The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.
20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early stage cervical cancer | Experimental | Other: Blood samplesPatients with cervical cancer eligible for surgery, stage IA1 to IB2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman >18 years old
- Cervical cancer confirmed by histology
- Early stage eligible for immediate surgical treatment (or post-brachytherapy): stages IA1, 1A2, 1B1 and IB2 with or without emboli determined by MRI performed as part of the treatment
- Histology : epidermoid carcinoma and adenocarcinoma
- Valid Social Security
Key exclusion criteria (6 listed)
- Advanced stage (Stage IB3 and more)
- Concomitant cancer
- Pregnant or breastfeeding woman
- Vulnerable person (Article L1121-6 of the Public Health Code)
- Participation to other study with an exclusion period still in progress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesPeripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation. | Other | Early stage cervical cancer |
Primary outcome
Number of circulating tumor cell detected after cervical cancer surgery.
Time frame: Within 48 hours after surgery.
Detection of the presence of at least one circulating tumor cell from blood samples taken during surgery (one CTC per 7.5mL of blood or increase of at least one CTC if CTC is present pre-operatively)
1 secondary outcome
Evaluation of disease-free survival
Time frame: Two points at the 3rd and 5th years
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 22 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Cervical Cancer Stage IA1 and Cervical Cancer Stage IB1, run by University Hospital, Montpellier at 3 sites in France.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating tumor cell detected after cervical cancer surgery. (time frame: Within 48 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.