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Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608346
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth will be included. These patients will be followed up during 30 months (2,5 years) with mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation detection and circulating tumor cells detection (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy).

Condition or disease Intervention/treatment Phase
Women With BRCA1 Germline Deleterious Mutation Procedure: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)
Actual Study Start Date : November 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Blood sampling Procedure: Blood sampling

Patients will have a blood draw at each visit to the hospital,

  • with a maximum of 1 blood draw every 3 months, in absence of any abnormal clinical/radiological exam
  • with a maximum of 1 blood draw every week, in case of abnormal clinical/radiological exam that requires further investigation




Primary Outcome Measures :
  1. Sensitivity of plasma TP53 mutation detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation [ Time Frame: Up to 42 months ]
    Sensitivity = % of patients with detectable levels of mutated TP53 ctDNA among those who experience a new tumor growth (relapse and/or new tumor).

  2. Specificity of plasma TP53 mutation detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation [ Time Frame: Up to 42 months ]
    Specificity = % of patients with undetectable levels of mutated TP53 ctDNA among those who don't experience a new tumor growth (diagnosed within 6 months after the blood draw).


Secondary Outcome Measures :
  1. Positive predictive value for mutated TP53 ctDNA [ Time Frame: Up to 42 months ]
    Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when mutated TP53 ctDNA is detectable.

  2. Negative predictive value for mutated TP53 ctDNA [ Time Frame: Up to 42 months ]
    Negative predictive value = Probability of being without tumor growth when mutated TP53 ctDNA is not detectable.

  3. Sensitivity of circulating tumor cells detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation [ Time Frame: Up to 42 months ]
    Sensitivity = % of patients with detectable levels of circulating tumor cells among those who experience a new tumor growth (relapse and/or new tumor).

  4. Specificity of circulating tumor cells detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation [ Time Frame: Up to 42 months ]
    Specificity = % of patients with undetectable levels of circulating tumor cells among those who don't experience a new tumor growth (diagnosed within 6 months after the blood draw).

  5. Positive predictive value for circulating tumor cells [ Time Frame: Up to 42 months ]
    Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when circulating tumor cells is detectable.

  6. Negative predictive value for circulating tumor cells [ Time Frame: Up to 42 months ]
    Negative predictive value = Probability of being without tumor growth when circulating tumor cells is not detectable.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with no evidence of any invasive tumor mass at inclusion (clinical and, if any, radiological exams)
  2. Carriers of known germline BRCA1 deleterious mutation (a personal history of cancer is NOT mandatory).
  3. Age ≥ 30 years for patient with personal previous history of cancer
  4. Age ≥ 40 years for patient without personal previous history of cancer
  5. Patient who a follow-up visit is scheduled in the including center at least once a year
  6. Patient having health care insurance
  7. Signed informed consent by patient

Exclusion Criteria:

  1. Patient presenting with invasive tumor masses (e.g. stage IV cancer or localized cancer not yet surgically removed)
  2. Carriers of germline BRCA1 variant of unknown significance
  3. Carriers of germline BRCA2 deleterious mutation or variant
  4. Individuals with a low risk of BRCA1-related tumor growth, i.e. women who underwent prophylactic bilateral mastectomy AND adnexectomy.
  5. Any medical or other condition that in the Investigator's opinion rendered the patient unsuitable for this study
  6. Patient deprived from ability to decide on her own.
  7. Patient unable to have a regular follow up for geographical, social or psychological reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608346


Locations
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France
Centre Léon Bérard
Lyon, France, 69273
Institut Curie
Paris, France, 75005
Hôpital René Huguenin - Institut Curie
Saint-cloud, France, 92210
Institut Gustave ROUSSY
Villejuif, France, 94805
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Jean-Yves PIERGA, DR Institut Curie

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02608346    
Other Study ID Numbers: IC 2014-05
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Keywords provided by Institut Curie:
Circulating tumor DNA
BRCA1 mutation
Circulating tumor cells