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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03302884

Acronym

CIDOC

Enrollment

150

Registered

2017-10-05

Start date

2018-10-10

Completion date

2023-10-30

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Carcinoma

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.

Interventions

OTHERbiological sampling

Tumor and blood samples

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	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	Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir

Countries

France

Contacts

Primary ContactDOMINIQUE GENRE, MD

drci.up@ipc.unicancer.fr33 4 91 22 37 78

Backup ContactMargot BERLINE, MSc, MBA