Circulating Tumor DNAPROMECINCT05415787
Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.
An observational study of Circulating Tumor DNA and Metastatic Prostate Cancer, run by University Hospital, Tours at 1 site in France.
Trial summary
Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Circulating Tumor DNA, Metastatic Prostate Cancer
- What is being tested?
- Blood sample and Urine sample
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2022to 18 Jan 2024
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic prostate cancer
Who may be able to join
- Age > 18 years
- Metastatic prostate cancer
- Archived tissue sample available for testing for somatic variants of HRR genes (including BRCA1/BRCA2)
- Free, informed and signed consent for research
- Non inclusion criteria
- Refusal of blood and urine collection
- Patient cognitively incapable of signing consent to participate in this study
- Patient under guardianship or curatorship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.
Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.
Read the detailed description
The benefit of PARPi has been well established for ovarian (SOLO-1 study) and prostate cancer (PROFOUND study) with defects in the Homologous Recombination Repair (HRR) system due to BRCA1 or BRCA2 variants. Somatic variants in HRR genes are currently researched by Next Generation Sequencing (NGS). However, in metastatic prostate cancer, using formalin-fixed and paraffin-embedded (FFPE) samples, failure rate is around 30 % according to our retrospective datas, in agreement with the data of the PROFOUND study, highlighting a real pre-analytical matter when FFPE samples are used for NGS testing. Research of such alterations on circulating tumor DNA (ctDNA) extracted from plasma or urine could be a promising alternative test.
- Conditions
- Circulating Tumor DNA, Metastatic Prostate Cancer
- Being tested
- Blood sample, Urine sample
- Keywords
- Prostate cancer, ctDNA, HR genes
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care.
Urine sampleOther
Urine sample is taken during the consultation carried out for the patient's care
| Study group | Role | What they receive |
|---|---|---|
| adult patients with metastatic prostate cancer | Not described Receives: Other: Blood sample; Other: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating plasma tumour DNA
search for somatic variants of HRR genes (including BRCA1/BRCA2)
Measured: Baseline
Circulating urine tumour DNA
search for somatic variants of HRR genes (including BRCA1/BRCA2)
Measured: Baseline
FFPE tissue
search for somatic variants of HRR genes (including BRCA1/BRCA2)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start18 Aug 2022
- Primary completion17 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor DNAStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Tallegas, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415787
- Sponsor's protocol ID
- DR220119 PROMECI
- Acronym
- PROMECI
- Status last verified
- Feb 2024
- First submitted
- 8 Jun 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.
- ClinicalTrials.gov ID
- NCT05415787
- Acronym / sponsor ID
- PROMECI / DR220119 PROMECI
- Conditions
- Circulating Tumor DNA, Metastatic Prostate Cancer
- Keywords
- Prostate cancer, ctDNA, HR genes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 13 Jun 2022 (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.
Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.
Detailed description
The benefit of PARPi has been well established for ovarian (SOLO-1 study) and prostate cancer (PROFOUND study) with defects in the Homologous Recombination Repair (HRR) system due to BRCA1 or BRCA2 variants. Somatic variants in HRR genes are currently researched by Next Generation Sequencing (NGS). However, in metastatic prostate cancer, using formalin-fixed and paraffin-embedded (FFPE) samples, failure rate is around 30 % according to our retrospective datas, in agreement with the data of the PROFOUND study, highlighting a real pre-analytical matter when FFPE samples are used for NGS testing. Research of such alterations on circulating tumor DNA (ctDNA) extracted from plasma or urine could be a promising alternative test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with metastatic prostate cancer | – | Other: Blood sample, Other: Urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic prostate cancer
Key inclusion criteria (8 listed)
- Age > 18 years
- Metastatic prostate cancer
- Archived tissue sample available for testing for somatic variants of HRR genes (including BRCA1/BRCA2)
- Free, informed and signed consent for research
- Non inclusion criteria
Key exclusion criteria (0 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 |
|---|---|---|
| Blood sample2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care. | Other | adult patients with metastatic prostate cancer |
| Urine sampleUrine sample is taken during the consultation carried out for the patient's care | Other | adult patients with metastatic prostate cancer |
Primary outcome
Circulating plasma tumour DNA
Time frame: Baseline
search for somatic variants of HRR genes (including BRCA1/BRCA2)
Circulating urine tumour DNA
Time frame: Baseline
search for somatic variants of HRR genes (including BRCA1/BRCA2)
FFPE tissue
Time frame: Baseline
search for somatic variants of HRR genes (including BRCA1/BRCA2)
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 1 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Matthias Tallegas principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor DNA and Metastatic Prostate Cancer, run by University Hospital, Tours at 1 site in France.
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 8 inclusion and 0 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Circulating plasma tumour DNA (time frame: Baseline). The study lists 3 primary outcomes in all. 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 1 Mar 2024.