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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03749681
Other study ID # TANGO (29BRC18.0013)
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2018
Est. completion date March 28, 2020

Study information

Verified date March 2018
Source University Hospital, Brest
Contact Jean-Philippe METGES
Phone 02-98-22-33-62
Email jean-philippe.metges@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 306
Est. completion date March 28, 2020
Est. primary completion date March 28, 2020
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Brest Novartis

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report statistical analysis (%) 03/31/2020
Primary All anticancer treatment description in neuroendocrine tumors of 3 specific histological grade (G1, 2 or 3) statistical analysis (%) 03/31/2020
Primary Histology, differentiation status qualitative description (text) 03/31/2020
Primary mitotic index and proliferation idex of the tumor statistical analysis (%) 03/31/2020
Primary Response rate statistical analysis (%) 03/31/2020
Primary progression free survival statistical analysis (months) with Kaplan meier analysis; data provided by the medical file 03/31/2020
Primary overall survival statistical analysis (months) with Kaplan meier analysis; data provided by the medical file 03/31/2020
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