Neuroendocrine TumorsTANGONCT03749681
Neuroendocrine Tumors of Old Patients in the West of France
An observational study of Neuroendocrine Tumors, run by University Hospital, Brest at 1 site in France.
Trial summary
Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A national network for the management of sporadic and hereditary malignant neuro-ENdocrine Tumor (RENATEN) is in charged of coordinating this specific… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2018to 28 Mar 2020
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with a neuroendocrine tumor whose medical file was analysed by RENATEN group between 2014 and 2017 in 4 western regions
Who may be able to join
- 75 years old or over at the time of diagnosis
- Patient with G1/G2/G3 neuroendocrine tumor diagnosed by pathological analysis
- Patient whose medical file was examined by RENATEN (National Network for the treatment of neuro-ENdocrine sporadic and hereditary disease Tumor) meetings or other multidisciplinary consultation meeting between 01/01/2014 and 31/12/2017
- Patient with care in private and public centers in the West of France
Who cannot join
- Patient with cancer other than a neuroendocrine tumor
- Patient with a G4 neuroendocrine tumor
- Patient who has objected to the study and collection of his medical data
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
Delphine DENIEL LAGADEC contact
France1 site
CHRU de Brest
Brest, 29609
Jean-Philippe Metges, jean-philippe.metges@chu-brest.fr
About this study
Official title: Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France
Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A national network for the management of sporadic and hereditary malignant neuro-ENdocrine Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French National Cancer INstitute (INCa) Rare Cancer Plan.
The project is in the form of an analysis of elderly population (75 years or over) with a diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be analysed in order to improve the care of rare cancer patients.
- Conditions
- Neuroendocrine Tumors
- Keywords
- Neuroendocrine Tumors, 75 y and over patients, Oncogeriatric follow-up, Oncologic care
- Medical subject headings
- Neuroendocrine Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report
statistical analysis (%)
Measured: 03/31/2020
All anticancer treatment description in neuroendocrine tumors of 3 specific histological grade (G1, 2 or 3)
statistical analysis (%)
Measured: 03/31/2020
Histology, differentiation status
qualitative description (text)
Measured: 03/31/2020
mitotic index and proliferation idex of the tumor
statistical analysis (%)
Measured: 03/31/2020
Response rate
statistical analysis (%)
Measured: 03/31/2020
progression free survival
statistical analysis (months) with Kaplan meier analysis; data provided by the medical file
Measured: 03/31/2020
overall survival
statistical analysis (months) with Kaplan meier analysis; data provided by the medical file
Measured: 03/31/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study startDec 2018 (estimated)
- Primary completion28 Mar 2020 (estimated)
- Study completion28 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749681
- Sponsor's protocol ID
- TANGO (29BRC18.0013)
- Acronym
- TANGO
- Status last verified
- Mar 2018
- First submitted
- 5 Apr 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- 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 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France
- ClinicalTrials.gov ID
- NCT03749681
- Acronym / sponsor ID
- TANGO / TANGO (29BRC18.0013)
- Conditions
- Neuroendocrine Tumors
- Keywords
- Neuroendocrine Tumors, 75 y and over patients, Oncogeriatric follow-up, Oncologic care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Dec 2018 (estimated)
- Primary completion
- 28 Mar 2020 (estimated)
- Study completion
- 28 Mar 2020 (estimated)
- First posted
- 21 Nov 2018 (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.
Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A national network for the management of sporadic and hereditary malignant neuro-ENdocrine Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French National Cancer INstitute (INCa) Rare Cancer Plan.
The project is in the form of an analysis of elderly population (75 years or over) with a diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be analysed in order to improve the care of rare cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with a neuroendocrine tumor whose medical file was analysed by RENATEN group between 2014 and 2017 in 4 western regions
Key inclusion criteria (4 listed)
- 75 years old or over at the time of diagnosis
- Patient with G1/G2/G3 neuroendocrine tumor diagnosed by pathological analysis
- Patient whose medical file was examined by RENATEN (National Network for the treatment of neuro-ENdocrine sporadic and hereditary disease Tumor) meetings or other multidisciplinary consultation meeting between 01/01/2014 and 31/12/2017
- Patient with care in private and public centers in the West of France
Key exclusion criteria (4 listed)
- Patient with cancer other than a neuroendocrine tumor
- Patient with a G4 neuroendocrine tumor
- Patient who has objected to the study and collection of his medical data
- Refusal of participation
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
Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report
Time frame: 03/31/2020
statistical analysis (%)
All anticancer treatment description in neuroendocrine tumors of 3 specific histological grade (G1, 2 or 3)
Time frame: 03/31/2020
statistical analysis (%)
Histology, differentiation status
Time frame: 03/31/2020
qualitative description (text)
mitotic index and proliferation idex of the tumor
Time frame: 03/31/2020
statistical analysis (%)
Response rate
Time frame: 03/31/2020
statistical analysis (%)
progression free survival
Time frame: 03/31/2020
statistical analysis (months) with Kaplan meier analysis; data provided by the medical file
overall survival
Time frame: 03/31/2020
statistical analysis (months) with Kaplan meier analysis; data provided by the medical file
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- 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.
Delphine DENIEL LAGADEC contact
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 Neuroendocrine Tumors, run by University Hospital, Brest 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 4 inclusion and 4 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 21 Nov 2018. 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 Jean-Philippe METGES (02-98-22-33-62, jean-philippe.metges@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report (time frame: 03/31/2020). The study lists 7 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 21 Nov 2018.