Study of Circulating Tumor Cells Before and After Treatme... | NCT01573494

Studies
Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

NCT01573494

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Jun 26, 2014Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Melanoma

Interventions

Sampling of blood

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Mar 23, 2012

First Submission Date that Met QC Criteria

Apr 5, 2012

First Posted Date

Apr 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2014

Last Update Posted Date

Jun 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.

Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.

Secondary objectives:

determine the percentage of patients with metastatic melanoma with melanoma cells circulating
seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma
seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metastatic melanoma patients	Experimental	Sampling of blood before and after chemotherapy	Other: Sampling of blood

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sampling of blood	Other	7,5 ml of blood	Metastatic melanoma patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measuring the number of circulating melanoma cells/ml in blood	Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.	baseline and 3 months

Secondary Outcomes

Measure	Description	Time Frame
number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test	Calculating the number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test before and after treatment.	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients > or = 18 years
Patients with advanced melanoma stage IIIC (unresectable) or stage IV
Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month
Patients who signed informed consent
Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology
Patients with a life expectancy greater than 3 months
Patients with melanoma measurable by RECIST version 1.1
Patients with venous good for venipuncture

Exclusion Criteria:

Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma
Pregnant women or nursing
People vulnerable detainees, adults under guardianship or curatorship, minors.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Damien GIACCHERO, PH	Centre Hospitalier Universitaire de Nice	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice		Nice		06202	France

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D009369	Neoplasms
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided