Cancer of PancreasCamuneNCT05234450
Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas
An observational study of Cancer of Pancreas, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In this work, the investigators count through the integrated multi-omics analysis to identify different tumor subgroups in pancreatic neuroendocrine tumors and carcinomas regardless of their grade and stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 30 Jun 2022
- 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
- All sexes
- Adult, Older adult
Study population: Adult patient (≥18 years old) with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas
Who may be able to join
- Adult patient (≥18 years old)
- Subject with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas
- Subject with tumors or neuroendocrine carcinoma of the pancreas regardless of the stage of the disease
- Supported at the University Hospitals of Strasbourg between 01/01/2008 and 01/09/2019
- Near therapeutic blood count available (less than 6 months)
- Availability of frozen and/or paraffin tumor material
- Patients who have already given their consent for their biological resources to be kept at the CRB or in the anatomopathology department of the HUS, and subsequently reused, as well as the anonymous data associated with them, for scientific research purposes.
Who cannot join
- Opposition of the patient to participate in the study
- Diagnosis other than pancreatic neuroendocrine tumor
- Biological tissue from a patient who does not meet all the inclusion criteria
- Impossibility of giving informed information to the subject
- Patient under judicial protection En savoir plus sur ce texte sourceVous devez indiquer le texte source pour obtenir des informations supplémentaires Envoyer des commentaires Panneaux latéraux
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service d'Oncologie - CHU de Strasbourg - France
Strasbourg, 67091
Gabriel MALOUF, MD, PhD, 33 3 88 11 51 41, malouf.gabriel@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
In this work, the investigators count through the integrated multi-omics analysis to identify different tumor subgroups in pancreatic neuroendocrine tumors and carcinomas regardless of their grade and stage. To achieve this, they will resort to the use of next-generation sequencing approaches (RNAseq, then use of MCP Counter for the absolute quantification of the eight populations of immune cells in the tumor microenvironment), alterations in epigenetics with study of the methylome by MeDIP, ChIPseq, telomere (ALT) study, as well as correlation with peripheral blood neutrophil to lymphocyte ratio and immunohistochemistry data such as Ki67, p53, Rb, DAXX, ATRX, PDL1, immune cell labeling. This will be done on frozen or paraffin material. This work will provide a more complete biological picture of pancreatic neuroendocrine tumors and carcinomas.
- Conditions
- Cancer of Pancreas
- Keywords
- Cancer of Pancreas, Neuroendocrine Tumors, Carcinoma, Neuroendocrine
- Medical subject headings
- Pancreatic Neoplasms, Neuroendocrine Tumors, Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Dec 2021
- Primary completionJun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel MALOUF, MD, PhD, Principal investigator, Service d'Oncologie - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234450
- Sponsor's protocol ID
- 7561
- Acronym
- Camune
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2022
- Last updated
- 10 Feb 2022
- 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 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Characterization of Pancreatic Neuroendocrine Tumors and Carcinomas
- ClinicalTrials.gov ID
- NCT05234450
- Acronym / sponsor ID
- Camune / 7561
- Conditions
- Cancer of Pancreas
- Keywords
- Cancer of Pancreas, Neuroendocrine Tumors, Carcinoma, Neuroendocrine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Feb 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.
In this work, the investigators count through the integrated multi-omics analysis to identify different tumor subgroups in pancreatic neuroendocrine tumors and carcinomas regardless of their grade and stage. To achieve this, they will resort to the use of next-generation sequencing approaches (RNAseq, then use of MCP Counter for the absolute quantification of the eight populations of immune cells in the tumor microenvironment), alterations in epigenetics with study of the methylome by MeDIP, ChIPseq, telomere (ALT) study, as well as correlation with peripheral blood neutrophil to lymphocyte ratio and immunohistochemistry data such as Ki67, p53, Rb, DAXX, ATRX, PDL1, immune cell labeling. This will be done on frozen or paraffin material. This work will provide a more complete biological picture of pancreatic neuroendocrine tumors and carcinomas.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas
Key inclusion criteria (7 listed)
- Adult patient (≥18 years old)
- Subject with histologically confirmed tumor or neuroendocrine carcinoma of the pancreas
- Subject with tumors or neuroendocrine carcinoma of the pancreas regardless of the stage of the disease
- Supported at the University Hospitals of Strasbourg between 01/01/2008 and 01/09/2019
- Near therapeutic blood count available (less than 6 months)
Key exclusion criteria (5 listed)
- Opposition of the patient to participate in the study
- Diagnosis other than pancreatic neuroendocrine tumor
- Biological tissue from a patient who does not meet all the inclusion criteria
- Impossibility of giving informed information to the subject
- Patient under judicial protection En savoir plus sur ce texte sourceVous devez indiquer le texte source pour obtenir des informations supplémentaires Envoyer des commentaires Panneaux latéraux
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
Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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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.
Saïd CHAYER, PhD, HDR contact
Gabriel MALOUF, MD, PhD principal investigator
Service d'Oncologie - CHU de Strasbourg - France
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 Cancer of Pancreas, 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 7 inclusion and 5 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 10 Feb 2022. 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 Gabriel MALOUF, MD, PhD (33 3 88 11 51 41, malouf.gabriel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of the number of tumor subgroups by integrating data from all multi-omics analyses (time frame: 1 month). 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 10 Feb 2022.