Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749681
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date April 5, 2018
First Posted Date November 21, 2018
Last Update Posted Date November 21, 2018
Estimated Study Start Date December 2018
Estimated Primary Completion Date March 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2018)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neuroendocrine Tumors of Old Patients in the West of France
Official Title Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Neuroendocrine Tumors
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 20, 2018)
306
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 28, 2020
Estimated Primary Completion Date March 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jean-Philippe METGES 02-98-22-33-62 jean-philippe.metges@chu-brest.fr
Contact: Delphine DENIEL LAGADEC +33 2 98 22 39 80
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03749681
Other Study ID Numbers TANGO (29BRC18.0013)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Novartis
Investigators Not Provided
PRS Account University Hospital, Brest
Verification Date March 2018