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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02449-36 | Other Identifier | ANSM |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical and Biological Collection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constitution of a biological collection | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to 7 years after the first pre-registration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|
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Eligibility criteria for pre-registration:
Non eligibility criteria for pre-registration:
Inclusion criteria:
• Confirmed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer (IIB to IV FIGO stages)
Exclusion criteria:
• Dismissed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer , or other type of cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicia Probst, PhD | Contact | 33320295918 | promotion@o-lambret.fr | |
| Lucie BRESSON, MD, PhD | Contact | 33320295918 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | France |
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| Assessment of Quality of Life and level of anxiety/depression | Other | 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 |
|
| 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 |
| 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). | 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:
| 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). | 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 | Up to 7 years after the first pre-registration |
| To estimate overall survival (OS) and event-free survival (EFS) of patients |
| 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 |
| 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) | 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) | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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