NCT04656717

Brief Summary

The aim of this study was to measure the total cost of performing next-generation sequencing (NGS) in clinical practice in France, in both germline and somatic cancer genetics. The study was performed on 15 French representative cancer molecular genetics laboratories performing NGS panels' tests. The production cost was estimated using a micro-costing method with resources consumed collected in situ in each laboratory from a healthcare provider perspective. A top-down methodology for specific post-sequencing steps was used. Additional non-specific costs were also included and costs were detailed per step of the process.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2019

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

May 26, 2019

Last Update Submit

December 4, 2020

Conditions

Keywords

Next-generation sequencing (NGS)CostCancer diagnosis

Outcome Measures

Primary Outcomes (1)

  • Overall production cost

    The study is performed on 15 French representative cancer molecular genetics laboratories performing NGS panels' tests. The production cost is estimated using a micro-costing method with resources consumed collected in situ in each laboratory from a healthcare provider perspective. A top-down methodology for specific post-sequencing steps is used.

    through study completion, an average of 5 years

Interventions

Resources consumed were collected for each laboratory using a standardized questionnaire. The production costs were calculated for the overall process and resources consumed for each step were identified.

Eligibility Criteria

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

French laboratories (7 somatic genetics and 8 germline oncogenetic) currently performing NGS.The laboratories were chosen because they performed cancer diagnostics nationwide and presented the full spectrum of clinical indications and technical solutions

You may qualify if:

  • French genetics laboratories performing somatic and germline clinical NGS tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2019

First Posted

December 7, 2020

Study Start

March 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share