Breast CancerPANELNCT02664389
Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation
A study testing Genetic analysis in people with Breast Cancer and Ovarian Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
Despite relevant clinical and/or familial presentations suggesting a hereditary predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic analysis based on the phenotype are often non contributive. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Colorectal Cancer
- What is being tested?
- Genetic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2016to 15 Mar 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Older than 18 or parental agreement in case of children.
- For patient with early-onset breast cancer :
- Invasive breast cancer, regardless of histological type or stage, diagnosed before 31 years.
- Sporadic or familial presentation
- No genomic alterations of BRCA1, BRCA2 or TP53
- For patient with early-onset ovarian cancer :
Show all 20Show fewer
- Invasive ovarian cancer, regardless of histological type or stage, diagnosed before 41 years.
- Sporadic or familial presentation
- No genomic alterations of BRCA1, BRCA2
- Patient with early-onset colorectal cancer :
- Invasive colorectal cancer diagnosed before 31 years.
- Sporadic or familial presentation
- No genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation
- No genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation
- Patient with pediatric cancer :
- Non haematological tumour diagnosed before 16 years, with Li-Fraumeni presentation.
- No genomic alteration of TP53
- Patient with Multiple primary malignant tumours :
- Multiple synchronous or metachronous primary malignant tumors with early-onset
- No syndromic presentation
Who cannot join
- Any already known deleterious mutations according to the patient's phenotype
Trial locations and contacts
1 site in 1 country.
About this study
Despite relevant clinical and/or familial presentations suggesting a hereditary predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic analysis based on the phenotype are often non contributive. As somatic cancer genes are limited, the hypothesis is that the targeted next-generation sequencing of 200 genes, selected for their implications in cancers may contribute to the understanding of many selected patients' presentation by the identification of germline deleterious mutations, and may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.
- Conditions
- Breast Cancer, Ovarian Cancer, Colorectal Cancer, Pediatric Cancers, Multiple Primary Malignant Tumours
- Being tested
- Genetic analysis
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysisGenetic
Sequencing of 200 selected genes in the different study populations
| Study group | Role | What they receive |
|---|---|---|
| Genetic analysis of patient with early-onset breast cancer | Experimental | Sequencing of 200 selected genes in patient with early-onset breast cancer without genomic alterations of BRCA1, BRCA2 or TP53 Receives: Genetic: Genetic analysis |
| Genetic analysis of patient with early-onset ovarian cancer | Experimental | Sequencing of 200 selected genes in patient with early-onset ovarian cancer without genomic alterations of BRCA1, BRCA2 Receives: Genetic: Genetic analysis |
| Genetic analysis of patient with pediatric cancer | Experimental | Sequencing of 200 selected genes in patient with pediatric cancer without genomic alteration of TP53 Receives: Genetic: Genetic analysis |
| Genetic analysis of patient with early-onset colorectal cancer | Experimental | Sequencing of 200 selected genes in patient with early-onset colorectal cancer without genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation or without genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation Receives: Genetic: Genetic analysis |
| Genetic analysis of patient with multiple primary tumors | Experimental | Sequencing of 200 selected genes in patient with Multiple primary malignant tumors without syndromic presentation Receives: Genetic: Genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of germline deleterious mutations
Frequency of germline deleterious mutations will be assessed for the 200 selected genes using next generation sequencing method
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start1 Feb 2016
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Why it stopped: Difficulty in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry FREBOURG, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664389
- Sponsor's protocol ID
- 2015/160/HP
- Acronym
- PANEL
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2016
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation
- ClinicalTrials.gov ID
- NCT02664389
- Acronym / sponsor ID
- PANEL / 2015/160/HP
- Conditions
- Breast Cancer, Ovarian Cancer, Colorectal Cancer, Pediatric Cancers, Multiple Primary Malignant Tumours
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling patients
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 27 Jan 2016 (estimated)
- 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.
Despite relevant clinical and/or familial presentations suggesting a hereditary predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic analysis based on the phenotype are often non contributive. As somatic cancer genes are limited, the hypothesis is that the targeted next-generation sequencing of 200 genes, selected for their implications in cancers may contribute to the understanding of many selected patients' presentation by the identification of germline deleterious mutations, and may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Genetic analysis of patient with early-onset breast cancer | Experimental | Genetic: Genetic analysisSequencing of 200 selected genes in patient with early-onset breast cancer without genomic alterations of BRCA1, BRCA2 or TP53 |
| Genetic analysis of patient with early-onset ovarian cancer | Experimental | Genetic: Genetic analysisSequencing of 200 selected genes in patient with early-onset ovarian cancer without genomic alterations of BRCA1, BRCA2 |
| Genetic analysis of patient with pediatric cancer | Experimental | Genetic: Genetic analysisSequencing of 200 selected genes in patient with pediatric cancer without genomic alteration of TP53 |
| Genetic analysis of patient with early-onset colorectal cancer | Experimental | Genetic: Genetic analysisSequencing of 200 selected genes in patient with early-onset colorectal cancer without genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation or without genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation |
| Genetic analysis of patient with multiple primary tumors | Experimental | Genetic: Genetic analysisSequencing of 200 selected genes in patient with Multiple primary malignant tumors without syndromic presentation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Older than 18 or parental agreement in case of children.
- Invasive breast cancer, regardless of histological type or stage, diagnosed before 31 years.
- Sporadic or familial presentation
- No genomic alterations of BRCA1, BRCA2 or TP53
- Invasive ovarian cancer, regardless of histological type or stage, diagnosed before 41 years.
Key exclusion criteria (1 listed)
- Any already known deleterious mutations according to the patient's phenotype
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 |
|---|---|---|
| Genetic analysisSequencing of 200 selected genes in the different study populations | Genetic | Genetic analysis of patient with early-onset breast cancer, Genetic analysis of patient with early-onset colorectal cancer, Genetic analysis of patient with early-onset ovarian cancer, Genetic analysis of patient with multiple primary tumors, Genetic analysis of patient with pediatric cancer |
Primary outcome
Frequency of germline deleterious mutations
Time frame: Day 1
Frequency of germline deleterious mutations will be assessed for the 200 selected genes using next generation sequencing method
Results and safety
The study was stopped early (reason given: Difficulty in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
Thierry FREBOURG, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic analysis in people with Breast Cancer and Ovarian Cancer, run by University Hospital, Rouen 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 20 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: stopped early, as of the sponsor's last update on 6 May 2026. 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 was stopped early (reason given: Difficulty in enrolling patients). Results are not available in the source record.
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?
Frequency of germline deleterious mutations (time frame: Day 1). 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 6 May 2026.