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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.
The main objective is to explore the capacity of ctDNA to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnosis of disease relapse.
Prospective multicentre open-label study
During visits in the frame of management of the disease, blood samples will be collected at diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the following 2 years, and every year during the remainin time of follow-up. Tumor samples will be collected at surgery or through a biopsy.
Patients will then have a standard care follow-up for a period of 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological sampling in ovarian carcinoma | Experimental | Blood and tumor samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological sampling | Other | Tumor and blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse. | Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir | at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years |
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Inclusion Criteria:
Non inclusion Criteria:
Exclusion Criteria after histological exam:
Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DOMINIQUE GENRE, MD | Contact | 33 4 91 22 37 78 | drci.up@ipc.unicancer.fr | |
| Margot BERLINE, MSc, MBA | Contact | 33 4 91 22 37 78 | drci.up@ipc.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Renaud SABATIER, MD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Recruiting | Clermont-Ferrand | 63011 | France |
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| Label | URL |
|---|---|
| Description official web site of the sponsor | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
|
| Institut Du Cancer de Montpellier | Recruiting | Montpellier | 34298 | France |
|
| 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 |