Study of Circulating Tumoral DNA in Ovarian Cancer

NCT01350908 | Completed

• 1 other identifier: IC2010-03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment and development of circulating tumor DNA detection techniques

  Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.

  2 years

Secondary Outcomes (1)

• Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost.

  2 years

Study Arms (1)

Blood sampling

OTHER

Other: Blood sampling

Interventions

Blood sampling OTHER

30mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.

Blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years.
• Patient with invasive ovarian cancer stage II to IV from FIGO classification.
• Patient treated by surgery.
• Patient with tumor or metastasis available for TP53 status characterization
• Patient able to stand a blood collection.
• Signed written informed consent approved by AFSSAPS and CPP.

You may not qualify if:

• Patient without social protection / insurance.
• Borderline ovarian tumor.
• Non carcinoma ovarian tumor
• Patient with invasive ovarian cancer 5 years before diagnosis
• Current pregnancy and lactation.
• All social, medical, psychological, situations making the study impossible.
• Person deprived of liberty.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• LANTZ Olivier, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 10, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (1)