Neuroendocrine Tumors of Old Patients in the West of France (TANGO)

November 20, 2018 updated by: University Hospital, Brest

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Delphine DENIEL LAGADEC
  • Phone Number: +33 2 98 22 39 80

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with a neuroendocrine tumor whose medical file was analysed by RENATEN group between 2014 and 2017 in 4 western regions

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

March 28, 2020

Study Completion (Anticipated)

March 28, 2020

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TANGO (29BRC18.0013)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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