Cancer of the OvaryBCB-OVAIRENCT06969833
Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma
A study testing Constitution of a biological collection and Assessment of Quality of Life and level of anxiety/depression in people with Cancer of the Ovary and Cancer of the Fallopian Tube, run by Centre Oscar Lambret at 1 site in France.
Trial summary
Cancer of the ovary and/or peritoneum and/or fallopian tube have a very poor prognosis, and require the implementation of collaborative research tools and new innovative therapies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Ovary, Cancer of the Fallopian Tube, Peritoneal Cancer
- What is being tested?
- Constitution of a biological collection and Assessment of Quality of Life and level of anxiety/depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2025to 27 Jun 2032
- 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
- Confirmed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer (IIB to IV FIGO stages)
Who cannot join
- Dismissed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer , or other type of cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucie BRESSON, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Centre Oscar Lambret
Lille
Lucie BRESSON, MD, PhD, 33320295918
About this study
Official title: Study of Prognostic Factors Associated With Overall Survival in Patients Initially Treated for Advanced Ovarian and/or Peritoneum and/or Fallopian Tubes Carcinoma: Analysis Using a Prospective Clinico-Biological Database
Cancer of the ovary and/or peritoneum and/or fallopian tube have a very poor prognosis, and require the implementation of collaborative research tools and new innovative therapies. The main objective of this study is to implement prognostic model of overall survival on patients included prospectively as part of the initial treatment of advanced ovarian and/or peritoneum, and/or fallopian tubes carcinoma (this cohort corresponds to the "Turquoise" care pathway of the Oscar Lambret Center) regardless of the treatment carried out,, integrating both patient's and tumor's characteristics. A clinical and biological database is implemented for this purpose.
371 patients will be recruited over a 5-year period at the Oscar Lambret Center.
The active participation of each patient will be 2 years (from the date of pre-registration until the end of study participation, defined by the date of the last intervention specific to the research), then the data from standard care and survival data will be collected until the last follow-up of the last patient, 2 years after the last pre-registration.
Read the detailed description
This study is part of the management of patients with advanced ovarian and/or peritoneal carcinoma, and/or fallopian tubes (initial treatment) at the Oscar Lambret Center.
Once consent is obtained, pre-registration of patient on the trial is possible during initial care, from diagnosis and before the confirmation of FIGO stage; a trial number is assigned to the patient.
If the diagnosis of advanced invasive ovarian and/or peritoneal and/or fallopian tube carcinoma is confirmed (FIGO stage IIB to IV), the patient is included. On the contrary (FIGO stage IA to IIA, or other disease), patient is not included on the trial and excluded from analysis.
Pre-registration and inclusion are possible the same day if the definitive FIGO stage is confirmed.
However, this project differs from standard care with:
- an additional blood sample, collected once inclusion is confirmed (28ml)
- left-over routine samples collected from pre-registration until two years after pre-registration (tumor samples, ascites, zetc.)
- questionnaires about quality of life (QLQ-C30, QLQ-OV28) and anxiety (HADS) are completed after pre-registration, then after 3 and 6 courses of systemic treatment (at the time of laparoscopy or surgery), then every 3 months, up to 2 years after pre-registration. Patients can choose printed and/or digital questionnaires.
- clinical data are entered into a trial-specific database ; in addition to overall survival, numerous variables will be studied, notably the clinical and socio-economic characteristics of the patients, their planned and effective treatment, the morbidity of treatments, event-free survival, evolution of the quality of life, etc.
- Translational research works will be implemented later on left-over routine samples.
- Being tested
- Constitution of a biological collection, Assessment of Quality of Life and level of anxiety/depression
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constitution of a biological collectionOther
- Left-over tissue samples (tumor tissue of different nature) frozen and secured in paraffin, and derived from standard care, are collected at study entrance until the end of oncologic treatment.
- One blood sample of 28mL is collected once inclusion is confirmed
Assessment of Quality of Life and level of anxiety/depressionOther
Questionnaires QLQ-C30, OV-28 and HADS are completed by the patients after pre-registration, then after 3 and 6 cycles of systemic treatment, and every 3 months up to 2 years after pre-registration
| Study group | Role | What they receive |
|---|---|---|
| Clinical and Biological Collection | Experimental | Not described Receives: Other: Constitution of a biological collection; Other: Assessment of Quality of Life and level of anxiety/depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify prognostic factors associated with overall survival on patients included prospectively as part of the initial treatment integrating both patient's and tumor's characteristics, using a multivariate Cox model.
Overall survival (OS) will defined as the time from the date of histological diagnosis to the date of death whatever the cause.
Post-relapse OS will be defined as the time from the date of first recurrence to the date of death from any cause.
The multivariate Cox model will be used to analyze the association of overall survival with prognostic factors:
- Patient's characteristics: age, weight, body-surface area, Performance status score, ASA score (Physical Status Classification System), antecedents and comorbidities
- FIGO stage at diagnosis
- Histological characteristics and histological subtype of tumor: high-grade serous, low-grade serous, endometrioid, clear-cell, mucinous, undifferentiated carcinoma
- Tumor genetics: HRD or HRP phenotype, methylation, etc.
- Tumor microenvironment: presence of tumor-infiltrating lymphocytes, presence of tumor-associated Macrophages, and expression of programmed cell death protein-1
Measured: Up to 7 years after the first pre-registration
Secondary outcomes (12)
To develop a prospective clinico-biological database of patients with advanced ovarian and/or peritoneal and/or fallopian tube carcinoma included during first-line treatment
- Clinical database created, functional and completed regularly.
- Biological collection constitued from additional blood samples (1 blood sample of 28ml per patient at the time of inclusion) and from biological extra-samples of standard care (biopsy, ascites)
Measured: Up to 7 years after the first pre-registration
To develop and validate prognostic models of event-free survival (EFS) on patients included prospectively as part of the initial treatment, integrating both patient's and tumor's characteristics, using a multivariate Cox model
- Event-free survival will be defined as the time from the date of histological diagnosis to the date of progression, relapse or death from any cause. Patients alive and event-free at the time of the last report will be censored at this date.
- Post-relapse event-free survival will be defined as the time from the date of the first recurrence to the date of the next event: progression, relapse or death from any cause. Patients who are alive and event-free at the latest will be censored at this date.
- The multivariate Cox model will be used to analyze the association of EFS with: Patient's characteristics: age, weight, body-surface area, Performance status score, ASA score (Physical Status Classification System), antecedents and comorbidities ; FIGO stage at diagnosis ; Histological characteristics and histological subtype of tumor ; Tumor genetics: HRD or HRP phenotype, methylation, etc. ; Tumor microenvironment: presence of tumor-infiltrating lymphocytes, etc.
Measured: Up to 7 years after the first pre-registration
To describe both initial characteristics of the patients and their disease characteristics
Clinical data of patients and disease characteristics will be described using traditional methods of descriptive statistics.
The clinical data include: age, weight, BSA, OMS score, ASA score (Physical Status Classification System), French deprivation index, medical history and comorbidities Disease characteristics include: FIGO stage, ascite, result of biological dosages (CA-125, CA-19.9, inhibine, ACE: carcinoma embryonic antigen), histology, carcinosis index Categorical variables will be presented as frequency and percentage Continuous variables will be presented as median with their extremes or interquartiles, and as mean with standard deviation (the list of data can't be detailed exhaustively in CT.gov).
Measured: At baseline
To describe the therapeutic management of these patients, as planned initially and finally carried out
The data obtained from standard care will described with usual descriptive statistics:
- Rate of surgery, complete or not
- Delay/timing of surgery
- Rate of systemic treatment: type of chemotherapy and number of courses This multiple measures will be aggregated to mesure the rate of patients receiving the treatment as planned initially, and the rate of patients receiving a treatment different as planned initially.
Measured: Up to 7 years after the first pre-registration
To describe the morbidity events of first-line treatments
The number of events will be described by type and by grade (according to NCI-CTCAE V6.0 scale), and for the different phases of treatment (neoadjuvant chemotherapy, surgery, adjuvant chemotherapy).
Measured: Up to 7 years after the first pre-registration
To describe the distribution of events (recurrence or progression) on patients who have received platinum treatment
These events will be described according to their time of occurrence in relation to the platinum treatment: during platinum treatment, less than 6 months after the end of platinum treatment, between 6 and 12 months after the end of platinum treatment, after 12 months of platinum treatment
Measured: Up to 7 years after the first pre-registration
To estimate overall survival (OS) and event-free survival (EFS) of patients
- Refer to primary outcome for definition and estimation of OS.
- Refer to secondary outcome linked to prognostic models for definition and estimation of EFS.
Measured: Up to 7 years after the first pre-registration
To estimate post-relapse overall survival (OS), and post-relapse event-free survival (EFS) of patients
- Refer to primary outcome for definition and estimation of OS.
- Refer to secondary outcome linked to prognostic models for definition and estimation of EFS.
Measured: Up to 7 years after the first pre-registration
To assess the quality of life of patients according to the score calculated with the health-related quality of life questionnaire (QLQ-C30)
Measured: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the quality of life of patients according to the score calculated with the ovarian cancer module of the health-related quality of life questionnaire (QLQ-OV28)
Measured: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the level of anxiety of patients according to the anxiety score calculated with Hospital Anxiety and Depression scale
Measured: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the level of depression of patients according to the depression score calculated with Hospital Anxiety and Depression scale
Measured: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start27 Jun 2025
- Primary completion27 Jun 2032 (estimated)
- Study completion27 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the OvaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 371 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969833
- Sponsor's protocol ID
- BCB-OVAIRE-2205
- Other IDs
- 2023-A02449-36
- Acronym
- BCB-OVAIRE
- Status last verified
- Mar 2026
- First submitted
- 6 Sep 2024
- Last updated
- 30 Mar 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognostic Factors Associated With Overall Survival in Patients Initially Treated for Advanced Ovarian and/or Peritoneum and/or Fallopian Tubes Carcinoma: Analysis Using a Prospective Clinico-Biological Database
- ClinicalTrials.gov ID
- NCT06969833
- Acronym / sponsor ID
- BCB-OVAIRE / BCB-OVAIRE-2205
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 371 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 27 Jun 2032 (estimated)
- Study completion
- 27 Jun 2032 (estimated)
- First posted
- 14 May 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.
Cancer of the ovary and/or peritoneum and/or fallopian tube have a very poor prognosis, and require the implementation of collaborative research tools and new innovative therapies. The main objective of this study is to implement prognostic model of overall survival on patients included prospectively as part of the initial treatment of advanced ovarian and/or peritoneum, and/or fallopian tubes carcinoma (this cohort corresponds to the "Turquoise" care pathway of the Oscar Lambret Center) regardless of the treatment carried out,, integrating both patient's and tumor's characteristics. A clinical and biological database is implemented for this purpose.
371 patients will be recruited over a 5-year period at the Oscar Lambret Center.
The active participation of each patient will be 2 years (from the date of pre-registration until the end of study participation, defined by the date of the last intervention specific to the research), then the data from standard care and survival data will be collected until the last follow-up of the last patient, 2 years after the last pre-registration.
Detailed description
This study is part of the management of patients with advanced ovarian and/or peritoneal carcinoma, and/or fallopian tubes (initial treatment) at the Oscar Lambret Center.
Once consent is obtained, pre-registration of patient on the trial is possible during initial care, from diagnosis and before the confirmation of FIGO stage; a trial number is assigned to the patient.
If the diagnosis of advanced invasive ovarian and/or peritoneal and/or fallopian tube carcinoma is confirmed (FIGO stage IIB to IV), the patient is included. On the contrary (FIGO stage IA to IIA, or other disease), patient is not included on the trial and excluded from analysis.
Pre-registration and inclusion are possible the same day if the definitive FIGO stage is confirmed.
However, this project differs from standard care with:
- an additional blood sample, collected once inclusion is confirmed (28ml)
- left-over routine samples collected from pre-registration until two years after pre-registration (tumor samples, ascites, zetc.)
- questionnaires about quality of life (QLQ-C30, QLQ-OV28) and anxiety (HADS) are completed after pre-registration, then after 3 and 6 courses of systemic treatment (at the time of laparoscopy or surgery), then every 3 months, up to 2 years after pre-registration. Patients can choose printed and/or digital questionnaires.
- clinical data are entered into a trial-specific database ; in addition to overall survival, numerous variables will be studied, notably the clinical and socio-economic characteristics of the patients, their planned and effective treatment, the morbidity of treatments, event-free survival, evolution of the quality of life, etc.
- Translational research works will be implemented later on left-over routine samples.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical and Biological Collection | Experimental | Other: Constitution of a biological collection, Other: Assessment of Quality of Life and level of anxiety/depression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer (IIB to IV FIGO stages)
Key exclusion criteria (1 listed)
- Dismissed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer , or other type of cancer
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 |
|---|---|---|
| Constitution of a biological collection* Left-over tissue samples (tumor tissue of different nature) frozen and secured in paraffin, and derived from standard care, are collected at study entrance until the end of oncologic treatment. * One blood sample of 28mL is collected once inclusion is confirmed | Other | Clinical and Biological Collection |
| Assessment of Quality of Life and level of anxiety/depressionQuestionnaires QLQ-C30, OV-28 and HADS are completed by the patients after pre-registration, then after 3 and 6 cycles of systemic treatment, and every 3 months up to 2 years after pre-registration | Other | Clinical and Biological Collection |
Primary outcome
To identify prognostic factors associated with overall survival on patients included prospectively as part of the initial treatment integrating both patient's and tumor's characteristics, using a multivariate Cox model.
Time frame: Up to 7 years after the first pre-registration
Overall survival (OS) will defined as the time from the date of histological diagnosis to the date of death whatever the cause. Post-relapse OS will be defined as the time from the date of first recurrence to the date of death from any cause. The multivariate Cox model will be used to analyze the association of overall survival with prognostic factors: * Patient's characteristics: age, weight, body-surface area, Performance status score, ASA score (Physical Status Classification System), antecedents and comorbidities * FIGO stage at diagnosis * Histological characteristics and histological subtype of tumor: high-grade serous, low-grade serous, endometrioid, clear-cell, mucinous, undifferentiated carcinoma * Tumor genetics: HRD or HRP phenotype, methylation, etc. * Tumor microenvironment: presence of tumor-infiltrating lymphocytes, presence of tumor-associated Macrophages, and expression of programmed cell death protein-1
12 secondary outcomes
To develop a prospective clinico-biological database of patients with advanced ovarian and/or peritoneal and/or fallopian tube carcinoma included during first-line treatment
Time frame: Up to 7 years after the first pre-registration
To develop and validate prognostic models of event-free survival (EFS) on patients included prospectively as part of the initial treatment, integrating both patient's and tumor's characteristics, using a multivariate Cox model
Time frame: Up to 7 years after the first pre-registration
To describe both initial characteristics of the patients and their disease characteristics
Time frame: At baseline
To describe the therapeutic management of these patients, as planned initially and finally carried out
Time frame: Up to 7 years after the first pre-registration
To describe the morbidity events of first-line treatments
Time frame: Up to 7 years after the first pre-registration
To describe the distribution of events (recurrence or progression) on patients who have received platinum treatment
Time frame: Up to 7 years after the first pre-registration
To estimate overall survival (OS) and event-free survival (EFS) of patients
Time frame: Up to 7 years after the first pre-registration
To estimate post-relapse overall survival (OS), and post-relapse event-free survival (EFS) of patients
Time frame: Up to 7 years after the first pre-registration
To assess the quality of life of patients according to the score calculated with the health-related quality of life questionnaire (QLQ-C30)
Time frame: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the quality of life of patients according to the score calculated with the ovarian cancer module of the health-related quality of life questionnaire (QLQ-OV28)
Time frame: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the level of anxiety of patients according to the anxiety score calculated with Hospital Anxiety and Depression scale
Time frame: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
To assess the level of depression of patients according to the depression score calculated with Hospital Anxiety and Depression scale
Time frame: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration
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 30 Mar 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.
Lucie BRESSON, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constitution of a biological collection and Assessment of Quality of Life and level of anxiety/depression in people with Cancer of the Ovary and Cancer of the Fallopian Tube, run by Centre Oscar Lambret at 1 site 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 1 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 30 Mar 2026. 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 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 Alicia Probst, PhD (33320295918, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify prognostic factors associated with overall survival on patients included prospectively as part of the initial treatment integrating both patient's and tumor's characteristics, using a multivariate Cox model. (time frame: Up to 7 years after the first pre-registration). 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 30 Mar 2026.