NCT02406235

Brief Summary

The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic counselling quality and satisfaction with a new onco-genetic BRCA testing model.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
710

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
3 countries

26 active sites

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

First Submitted

Initial submission to the registry

March 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

April 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

March 23, 2015

Last Update Submit

September 18, 2017

Conditions

Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

  • Assessing turnaround time with the new BRCA-testing pathway

    The primary objectives include a) assessing turnaround time with the new BRCA (Breast Cancer)-testing pathway; b) patient's assessment of pre-BRCA test onco-genetic counselling quality and satisfaction with the onco-genetic BRCA testing pathway; c) oncologists, and genetic counsellor's assessment of onco-genetic BRCA testing process. The study will be limited to patients with a diagnosis of ovarian cancer.

    participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling and completion of satisfaction survey or death, an expected average of 2 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study

You may qualify if:

  • Patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer
  • Patients aged 18 years or older at ovarian cancer diagnosis
  • Provision of written informed consent
  • Patient is able to read, write, and understand the material presented to them as part of this study, per the discretion of the physician

You may not qualify if:

  • Patients with low grade epithelial ovarian cancer or non-epithelial ovarian cancer
  • Patients enrolled in an interventional clinical trial for ovarian cancer or other malignancy at the time of conduct of this study
  • Patients with BRCA testing any time prior to the study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Research Site

San Francisco, California, United States

Location

Research Site

Gainesville, Florida, United States

Location

Research Site

Sarasota, Florida, United States

Location

Research Site

Augusta, Georgia, United States

Location

Research Site

Worcester, Massachusetts, United States

Location

Research Site

Hackensack, New York, United States

Location

Research Site

Lake Success, New York, United States

Location

Research Site

Mineola, New York, United States

Location

Research Site

The Bronx, New York, United States

Location

Research Site

Chapel Hill, North Carolina, United States

Location

Research Site

Providence, Rhode Island, United States

Location

Research Site

Brescia, IT, Italy

Location

Research Site

Genova, IT, Italy

Location

Research Site

Milan, IT, Italy

Location

Research Site

Modena, IT, Italy

Location

Research Site

Napoli, IT, Italy

Location

Research Site

Roma, IT, Italy

Location

Research Site

Torino, IT, Italy

Location

Research Site

A Coruña, SP, Spain

Location

Research Site

Barcelona, SP, Spain

Location

Research Site

Cáceres, SP, Spain

Location

Research Site

Córdoba, SP, Spain

Location

Research Site

Madrid, SP, Spain

Location

Research Site

Murcia, SP, Spain

Location

Research Site

Palma de Mallorca, SP, Spain

Location

Research Site

Zaragoza, SP, Spain

Location

Related Publications (1)

  • Colombo N, Huang G, Scambia G, Chalas E, Pignata S, Fiorica J, Van Le L, Ghamande S, Gonzalez-Santiago S, Bover I, Grana Suarez B, Green A, Huot-Marchand P, Bourhis Y, Karve S, Blakeley C. Evaluation of a Streamlined Oncologist-Led BRCA Mutation Testing and Counseling Model for Patients With Ovarian Cancer. J Clin Oncol. 2018 May 1;36(13):1300-1307. doi: 10.1200/JCO.2017.76.2781. Epub 2018 Mar 20.

    PMID: 29558274DERIVED

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

April 2, 2015

Study Start

April 21, 2015

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

US(11)IT(7)ES(8)