Pediatric Solid TumorsCS-PEDIANCT06171971
Clinical and Therapeutic Impact of Large Genomic Studies at Diagnosis in Pediatric Solid Cancers
An observational study of Pediatric Solid Tumors, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Pediatric solid tumors with an unfavorable prognosis remain a public health issue due to their morbidity and mortality and their rapidly evolving profile. They are defined by an expected overall survival of < 30%. Read more about this study
- Who is it for?
- Ages 1 year to 22 years
- Conditions the study is for
- Pediatric Solid Tumors
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2022to Dec 2023
- 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 1 year to 22 years
- All sexes
- Child, Adult
Study population: Patients of pediatric age up to 22 years included at the time of molecular analysis
Who may be able to join
- Patients of pediatric age up to 22 years included at the time of molecular analysis
- Histological carcinological diagnosis performed at HUS
- Carcinological follow-up performed at HUS
- Patients with a solid tumor of unfavorable prognosis, refractory or in relapse
- Molecular analysis performed on tumor or blood samples
- Adult patients who do not object to the re-use of their personal data for medical research purposes
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- Minor patients and their parents who do not object to the re-use of their personal data for scientific research purposes.
- Criteria for non-inclusion
- Molecular biology results not usable due to poor sample quality or insufficient genetic material
- Patients who have expressed their opposition to participate in the study
- Parental authority holders who have expressed their opposition to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'onco-hématologie pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
Natacha ENTZ-WERLE, MD, PhD, 33 3.88.12.87.94, natacha.entz-werle@chru-strasbourg.fr
Natacha ENTZ-WERLE, MD, PhD
About this study
Official title: Evaluation of the Clinical and Therapeutic Impact of Large Genomic Studies at Diagnosis in Pediatric Solid Cancers
Pediatric solid tumors with an unfavorable prognosis remain a public health issue due to their morbidity and mortality and their rapidly evolving profile. They are defined by an expected overall survival of < 30%. Progress has been made in genomic medicine with existing recommendations for the adult population, with the objective of personalized medicine. Recommendations for the pediatric population are still under consideration
- Conditions
- Pediatric Solid Tumors
- Keywords
- Pediatric solid tumors, BROAD GENOMIC STUDIES, SOLID CANCERS, Genomic medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the clinical and therapeutic impact of the systematic performance of molecular analyzes on solid tumors
The aim of this retrospective study is to improve and harmonize international practices
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start20 Jun 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171971
- Sponsor's protocol ID
- 8661
- Acronym
- CS-PEDIA
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Therapeutic Impact of Large Genomic Studies at Diagnosis in Pediatric Solid Cancers
- ClinicalTrials.gov ID
- NCT06171971
- Acronym / sponsor ID
- CS-PEDIA / 8661
- Conditions
- Pediatric Solid Tumors
- Keywords
- Pediatric solid tumors, BROAD GENOMIC STUDIES, SOLID CANCERS, Genomic medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Dec 2023 (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.
Pediatric solid tumors with an unfavorable prognosis remain a public health issue due to their morbidity and mortality and their rapidly evolving profile. They are defined by an expected overall survival of < 30%. Progress has been made in genomic medicine with existing recommendations for the adult population, with the objective of personalized medicine. Recommendations for the pediatric population are still under consideration
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 22 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients of pediatric age up to 22 years included at the time of molecular analysis
Key inclusion criteria (11 listed)
- Patients of pediatric age up to 22 years included at the time of molecular analysis
- Histological carcinological diagnosis performed at HUS
- Carcinological follow-up performed at HUS
- Patients with a solid tumor of unfavorable prognosis, refractory or in relapse
- Molecular analysis performed on tumor or blood samples
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.
Primary outcome
Retrospective description of the clinical and therapeutic impact of the systematic performance of molecular analyzes on solid tumors
Time frame: up to 12 months
The aim of this retrospective study is to improve and harmonize international practices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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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.
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 Pediatric Solid Tumors, run by University Hospital, Strasbourg, France 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 11 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha ENTZ-WERLE, MD, PhD (33 3.88.12.87.94, natacha.entz-werle@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the clinical and therapeutic impact of the systematic performance of molecular analyzes on solid tumors (time frame: up to 12 months). 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 15 Dec 2023.