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Study of Circulating Tumoral DNA in Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Curie
ClinicalTrials.gov Identifier:
NCT01350908
First received: May 6, 2011
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Condition Intervention
Ovarian Cancer
Other: Blood sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • Assessment and development of circulating tumor DNA detection techniques [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.


Secondary Outcome Measures:
  • Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The methods of detection which will be used such as the BEAMing, the PAP(pyrophosphorolysis activated polymerization) and the NGS(next sequencing generation is techniques of a big specificity capable of detecting a mutant copy among 1.104 wild copies for the BEAMing, 2.109 for the PAP and 1.105 for the NGS. The sensibility of these techniques is limited by the quantity of genomic DNA which we can extract from the sample of blood.


Enrollment: 25
Study Start Date: April 2011
Study Completion Date: December 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Blood sampling Other: Blood sampling
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.

Detailed Description:

Technique development:

In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.

Validation:

The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.

The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350908

Locations
France
Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: LANTZ Olivier, MD Institut Curie
  More Information

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01350908     History of Changes
Other Study ID Numbers: IC2010-03 
Study First Received: May 6, 2011
Last Updated: July 11, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 28, 2016