NCT02827565

Brief Summary

The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

July 6, 2016

Last Update Submit

August 7, 2018

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancerKras mutationNras mutationBraf mutation

Outcome Measures

Primary Outcomes (1)

  • Technical Optimization of KRAS, BRAF and NRAS mutations detection

    Optimize the detection of mutations of KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAf (exon 15) genes, using the next-generation sequencing technology from circulating tumor DNA in patients with metastatic colorectal cancer.

    1 day

Secondary Outcomes (1)

  • KRAS, NRAS et BRAF mutational status

    1 day

Study Arms (1)

CircuLOR-1

EXPERIMENTAL

KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (exon 15) mutations

Other: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Interventions

KRAS, NRAS et BRAF mutation analysis from circulating plasma DNAOTHER

10 ml blood sample

Also known as: NGS
CircuLOR-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  • Age ≥ 18 years
  • Patient information and written informed consent form signed
  • Patient must be affiliated to a social security system

You may not qualify if:

  • Patients whose health-cons indicates a blood sample 10mL
  • Age \< 18 years
  • Pregnant or breast feeding females
  • Persons deprived of liberty or under supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • GAVOILLE CELINE, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

  • HARLE ALEXANDRE

    Institut de Cancérologie de Lorraine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

February 3, 2016

Primary Completion

January 5, 2017

Study Completion

January 19, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)