Collection of Blood Specimens for Circulating Tumor Cell... | NCT01943500

Studies
Collection of Blood Specimens for Circulating Tumor Cell Analysis

NCT01943500

Sponsor

Viatar LLC

Status

Completed

Last Update Posted

Feb 15, 2017Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Breast Cancer
Prostate Cancer
Colorectal Cancer

Interventions

Not provided

Countries

United States

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

Feb 2017

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

Sep 30, 2013Actual

Primary Completion Date

Jan 28, 2014Actual

Completion Date

Aug 26, 2016Actual

First Submitted Date

Sep 10, 2013

First Submission Date that Met QC Criteria

Sep 14, 2013

First Posted Date

Sep 17, 2013Estimated

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

Feb 13, 2017

Last Update Posted Date

Feb 15, 2017Actual

Name	Class
Commonwealth Hematology-Oncology, P.C.	UNKNOWN

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

Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer or no prior history of cancer		Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter.	Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection.	Analysis will be performed within 96 hours following blood sample collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years of age
Written informed consent obtained
Confirmed diagnosis of stage 2-4 breast, prostate, or colorectal cancer, (OR) no prior history of cancer
Stage 2-4 treatment naive, metastatic, secondary, and recurrent cancer patients
Able to undergo blood collection prior to initiation of chemotherapy treatment, (OR) able to provide blood sample if subject is a non-cancer control subject

Exclusion Criteria:

Patients unable to understand the research protocol and/or provide informed consent.
Patients with known immunodeficiency, or pregnancy.

Accepts Healthy Volunteers

Yes

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

Confirmed patients with stage II-IV breast, prostate, or colorectal cancer, (Or) subjects with no prior history of cancer.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pedro M Sanz-Altamira, MD, PhD	Commonwealth Hematology-Oncology, P.C.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Commonwealth Hematology-Oncology, P.C.		Lawrence	Massachusetts	01841-2310	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D011471	Prostatic Neoplasms
D015179	Colorectal Neoplasms
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided