Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs

NCT02630654 | Completed

• 1 other identifier: A-99-52030-286
• Study Type: observational
• Target: 404
• Locations: 7 countries
• Sites: 25

Brief Summary

This exploratory study aims to evaluate the diagnostic, prognostic and response predictive value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an interesting approach to solve this question (Lundberg et al 2011).

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression Free Survival

  Up to 60 months

Secondary Outcomes (1)

• Change in oncological biomarker levels

  Baseline visit and follow-up visit [i.e. every 3 months during the first year, every 6 months for the remainder of the study] up to 60 months

Study Arms (2)

GEP NETs

Patients with a suspected diagnosis of metastatic GEP NETs

Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.

Healthy controls

Healthy controls matched by age and gender.

Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.

Interventions

This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician. OTHER

GEP NETs; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from a specialist clinic with a suspected diagnosis of metastatic GEP NETs and healthy controls matched by age and gender.

You may qualify if:

• Provision of written informed consent prior to any study related procedures.
• Suspected of suffering from a metastatic midgut NET or Pancreatic non-functional NET (WHO grade 1 or 2, up to 10% Ki67).
• Male or female aged 18 or older.

You may not qualify if:

• Previously treated for the NET disease with pharmaceutical treatment, Peptide Receptor Radionuclide Therapy (PRRT) or radiation therapy(surgery of primary tumour is accepted)
• Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
• Suffering from a malignant disease or previously treated for a malignant disease within the last 6 months.
• Suffering from a chronic inflammatory disease.
• Suffering from a renal and/or liver disease.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (25)

Unknown Facility

Aarhus, Denmark

Location

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Odense, Denmark

Location

North Estonia Medical Center

Tallinn, Estonia

Location

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Oulu, Finland

Location

Unknown Facility

Tampere, Finland

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Riga East University Hospital

Riga, Latvia

Location

The Hospital of Lithuanian Health Science

Kaunas, Lithuania

Location

Klaipėda University Hospital

Klaipėda, Lithuania

Location

National Cancer Institute

Vilnius, Lithuania

Location

Vilnius University Hospital

Vilnius, Lithuania

Location

Unknown Facility

Bergen, Norway

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Stavanger, Norway

Location

Unknown Facility

Trondheim, Norway

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Jönköping, Sweden

Location

Unknown Facility

Lund, Sweden

Location

Unknown Facility

Örebro, Sweden

Location

Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Unknown Facility

Umeå, Sweden

Location

Unknown Facility

Uppsala, Sweden

Location

Related Publications (1)

• Kjellman M, Knigge U, Welin S, Thiis-Evensen E, Gronbaek H, Schalin-Jantti C, Sorbye H, Joergensen MT, Johanson V, Metso S, Waldum H, Soreide JA, Ebeling T, Lindberg F, Landerholm K, Wallin G, Salem F, Schneider MDP, Belusa R. A Plasma Protein Biomarker Strategy for Detection of Small Intestinal Neuroendocrine Tumors. Neuroendocrinology. 2021;111(9):840-849. doi: 10.1159/000510483. Epub 2020 Jul 28.

  PMID: 32721955 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Frozen plasma will be saved in a biobank

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: March 24, 2014
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Locations

ES (1); NO (4); LA (2); SE (8); LI (4); DK (3); FI (3)