Clinical trial NCT03302884: Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
Official title: Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Carcinoma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2017-10-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Montpellier
country: France
facility: Institut Du Cancer de Montpellier
Study officials:
affiliation: Institut Paoli-Calmettes
name: Renaud SABATIER, MD
role: PRINCIPAL_INVESTIGATOR
References: