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

Ovarian Carcinoma Clinical Trial

— CIDOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03302884
• Other study ID #: CIDOC-IPC- 2016-008
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2019
• Source: Institut Paoli-Calmettes
• Contact: DOMINIQUE GENRE, MD
• Phone: 33 4 91 22 37 78
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms
• Recurrence

Intervention

Other:
• biological sampling
Tumor and blood samples

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Oscar Lambret	Lille
France	Institut Du Cancer de Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Description official web site of the sponsor