Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma (CIDOC)

Institut Paoli-Calmettes

Status: Unknown

Conditions: Ovarian Carcinoma

Treatments: Other: biological sampling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03302884

CIDOC-IPC- 2016-008

Details and patient eligibility

About

Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

Full description

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy.
2. Indication of preoperative and/or adjuvant chemotherapy.
3. Age ≥ 18 years old.
4. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
5. Signed written informed consent prior to any screening procedures being performed

Non inclusion Criteria:

1. Contraindication to surgical assessment.
2. Pathological diagnosis of mucinous carcinoma.
3. History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer).
4. Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol.
5. Patient in urgency situation, adult under legal protection, or unable to give his consent.

Exclusion Criteria after histological exam:

Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Biological sampling in ovarian carcinoma

Experimental group

Description:

Blood and tumor samples

Treatment:

Other: biological sampling