CancerNCT04656717
Cost of Cancer Diagnosis Using Next-generation Sequencing Targeted Gene Panels in Routine Practice
An observational study of Cancer, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Measure of the total cost of performing next-generation sequencing (NGS)
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- French genetics laboratories performing somatic and germline clinical NGS tests.
Who cannot join
- -
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Measure of the total cost of performing next-generation sequencing (NGS)
- Keywords
- Next-generation sequencing (NGS), Cost, Cancer diagnosis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of the total cost of performing next-generation sequencing (NGS)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656717
- Sponsor's protocol ID
- 29367707
- Status last verified
- Dec 2020
- First submitted
- 26 May 2019
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost of Cancer Diagnosis Using Next-generation Sequencing Targeted Gene Panels in Routine Practice: a Nationwide French Study
- ClinicalTrials.gov ID
- NCT04656717
- Acronym / sponsor ID
- 29367707
- Conditions
- Cancer
- Keywords
- Next-generation sequencing (NGS), Cost, Cancer diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Mar 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- French genetics laboratories performing somatic and germline clinical NGS tests.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of the total cost of performing next-generation sequencing (NGS)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. | Other | – |
Primary outcome
Overall production cost
Time frame: through study completion, an average of 5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Fondation Ophtalmologique Adolphe de Rothschild.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall production cost (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.