Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

Solid Tumor. Clinical Trial

— CTC-CEC-ADN  

Official title:

Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02220556
• Other study ID #: IC 2010-01
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2014
• Last updated: July 6, 2016
• Start date: December 2010
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Institut Curie
• Contact: Patricia Tresca, MD
• Phone: +33 (0) 1 56.24.57.65
• Email: patricia.tresca[@]curie.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or more

• Performance status from 0 to 4

• Patient treated followed for histologically confirmed solid tumor type of any of these localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma.

• Informed consent form signed.

Exclusion Criteria:

• Patient with history of other invasive cancer within 5 years.

• Patient treated for any non-invasive cancer

• Patient individually deprived of liberty or placed under the authority of a tutor

• Geographical condition potentially preventing compliance with the study protocol.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Solid Tumor.

Intervention

Procedure:
• Blood sampling

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Institut Mutualiste Montsouris	Paris
France	Institut Curie	Saint-Cloud

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTC, CEC or ctDNA incidence	number of CTC or CEC in 7.5ml of blood	3 years	No
Secondary	CTC and CEC molecular characterization	This outcome is self-explanatory.	3 years	No
Secondary	Circulating tumor DNA (ctDNA) detection and quantification	plasma mutation detection (number of copy)	3 years	No