Cost of Cancer Diagnosis Using Next-generation Sequencing Targeted Gene Panels in Routine Practice

Cost of Cancer Diagnosis Using Next-generation Sequencing Targeted Gene Panels in Routine Practice: a Nationwide French Study

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Measure of the total cost of performing next-generation sequencing (NGS)

• Study Type: Observational
• Enrollment (Actual): 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 26, 2019
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cost; Next-generation sequencing (NGS); Cancer diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 29367707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No