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Trial record 55 of 2734 for:    tumor | Neuroendocrine Tumors

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

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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

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.


Condition or disease
Neuroendocrine Tumors

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Study Type : Observational
Estimated Enrollment : 306 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : March 28, 2020
Estimated Study Completion Date : March 28, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Tumor description : localization of the tumor (digestive or others) provided by scan or anatomopathologic report [ Time Frame: 03/31/2020 ]
    statistical analysis (%)

  2. All anticancer treatment description in neuroendocrine tumors of 3 specific histological grade (G1, 2 or 3) [ Time Frame: 03/31/2020 ]
    statistical analysis (%)

  3. Histology, differentiation status [ Time Frame: 03/31/2020 ]
    qualitative description (text)

  4. mitotic index and proliferation idex of the tumor [ Time Frame: 03/31/2020 ]
    statistical analysis (%)

  5. Response rate [ Time Frame: 03/31/2020 ]
    statistical analysis (%)

  6. progression free survival [ Time Frame: 03/31/2020 ]
    statistical analysis (months) with Kaplan meier analysis; data provided by the medical file

  7. overall survival [ Time Frame: 03/31/2020 ]
    statistical analysis (months) with Kaplan meier analysis; data provided by the medical file



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749681


Contacts
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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

Locations
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France
CHRU de Brest Not yet recruiting
Brest, France, 29609
Contact: Jean-Philippe Metges       jean-philippe.metges@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Novartis

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03749681     History of Changes
Other Study ID Numbers: TANGO (29BRC18.0013)
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Brest:
Neuroendocrine Tumors
75 y and over patients
Oncogeriatric follow-up
Oncologic care

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue