Uterine Cervical NeoplasmsTRUST-GBNCT07204535
Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
An observational study of Uterine Cervical Neoplasms, run by Centre Paul Strauss at 2 sites in France.
Trial summary
This is a multicenter, prospective study aimed at providing information on the psychological effects (including post-traumatic stress symptoms) of utero-vaginal brachytherapy in patients with cervical cancer using self-administered questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Prospective questionnaires
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Nov 2025to 17 Nov 2031
- How long will I take part?
- 60 Months
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy
Who may be able to join
- Confirmed diagnosis of cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy;
- Squamous cell carcinoma or other histological types;
- WHO ≤ 2;
- Ability to complete validated questionnaires in French;
- Informed consent to participate in the study;
- Patients over 18 years old
Who cannot join
- Inability to understand or respond to questionnaires due to a cognitive disorder, intellectual disability, language barrier, or psychiatric disorder that impairs judgment;
- Patient under juridic protection;
- Pregnant or breastfeeding woman
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Groupement Hospitalier Sud - Hopital Lyon Sud
Pierre-Bénite, 69495
Ionela CARAIVAN, MD, 0478864251, promotion-rc@institut-strauss.fr
- Recruiting
ICANS
Strasbourg, 67033
George NOEL, MD, PhD, 368766767 ext. 33, promotion-rc@icans.eu
About this study
This is a multicenter, prospective study aimed at providing information on the psychological effects (including post-traumatic stress symptoms) of utero-vaginal brachytherapy in patients with cervical cancer using self-administered questionnaires. The study also aims to assess the persistence of these symptoms over time, up to 5 years after brachytherapy. The results could help identify patients at risk of post-traumatic stress in this context and develop appropriate psychological interventions to improve their psychological well-being during and after treatment.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Prospective questionnaires
- Keywords
- Brachytherapy, Post-TRaUmatic STress Disorder, Cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective questionnairesOther
Post-traumatic stress disorder Checklist version DSM-5 (PCL-5) and quality of life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patient with cervical cancer with an indication for uterovaginal brachytherapy | Not described Receives: Other: Prospective questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Stress Disorder evaluation
Evaluation with post-traumatic stress disorder Checklist version DSM-5 (PCL-5) - questionnaire with a Cut off score ≥ 32
Measured: at 2 months
Secondary outcomes (4)
Anxiety and Depression
Hospital Anxiety and Depression scale
Measured: until 60 months
Quality of Life (general module)
Evaluated with EORTC QLQ-C30 questionnaire
Measured: until 60 months
Quality of Life (cervical cancer module)
Evaluated with EORTC QLQ-CX24 questionnaire
Measured: until 60 months
Sexual Health evaluation
Sexual Health Questionnaire (EORTC SHQ-22)
Measured: until 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start17 Nov 2025
- Primary completion17 Nov 2030 (estimated)
- Study completion17 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- 80 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George NOEL, MD, PhD, Principal investigator, ICANS, CPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204535
- Sponsor's protocol ID
- 2024-004
- Other IDs
- 2025-A00672-47
- Acronym
- TRUST-GB
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-TRaUmatic STress Disorder Induced by Gynecological Brachytherapy
- ClinicalTrials.gov ID
- NCT07204535
- Acronym / sponsor ID
- TRUST-GB / 2024-004
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Brachytherapy, Post-TRaUmatic STress Disorder, Cervical cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 17 Nov 2030 (estimated)
- Study completion
- 17 Nov 2031 (estimated)
- First posted
- 2 Oct 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.
This is a multicenter, prospective study aimed at providing information on the psychological effects (including post-traumatic stress symptoms) of utero-vaginal brachytherapy in patients with cervical cancer using self-administered questionnaires. The study also aims to assess the persistence of these symptoms over time, up to 5 years after brachytherapy. The results could help identify patients at risk of post-traumatic stress in this context and develop appropriate psychological interventions to improve their psychological well-being during and after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with cervical cancer with an indication for uterovaginal brachytherapy | – | Other: Prospective questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy
Key inclusion criteria (6 listed)
- Confirmed diagnosis of cervical cancer with an indication for High-dose rate (HDR) or pulse-dose rate (PDR) uterovaginal brachytherapy;
- Squamous cell carcinoma or other histological types;
- WHO ≤ 2;
- Ability to complete validated questionnaires in French;
- Informed consent to participate in the study;
Key exclusion criteria (3 listed)
- Inability to understand or respond to questionnaires due to a cognitive disorder, intellectual disability, language barrier, or psychiatric disorder that impairs judgment;
- Patient under juridic protection;
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| Prospective questionnairesPost-traumatic stress disorder Checklist version DSM-5 (PCL-5) and quality of life questionnaires | Other | Patient with cervical cancer with an indication for uterovaginal brachytherapy |
Primary outcome
Post-Traumatic Stress Disorder evaluation
Time frame: at 2 months
Evaluation with post-traumatic stress disorder Checklist version DSM-5 (PCL-5) - questionnaire with a Cut off score ≥ 32
4 secondary outcomes
Anxiety and Depression
Time frame: until 60 months
Quality of Life (general module)
Time frame: until 60 months
Quality of Life (cervical cancer module)
Time frame: until 60 months
Sexual Health evaluation
Time frame: until 60 months
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 4 Jun 2026.
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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.
George NOEL, MD, PhD principal investigator
ICANS, CPS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Centre Paul Strauss at 2 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 3 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 4 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 2 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?
Contact Valérie SARTORI (368767223 ext. 33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Traumatic Stress Disorder evaluation (time frame: at 2 months). 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 4 Jun 2026.