NCT02613637

Brief Summary

Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

10.6 years

First QC Date

June 22, 2015

Last Update Submit

February 22, 2017

Conditions

Lung Cancer

Keywords

lung cancerregistry studyBiological Disease Profile

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    maximally 10 years

Interventions

RegistryOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with newly diagnosed or existent lung cancer of all LuCa BiO centers in Germany are intended to be registered with in the LuCa BiO Registry.

You may qualify if:

  • Patients with suspected diagnosis of lung cancer, or previously diagnosed lung cancer
  • Age ≥ 18 years. There is no upper age limit.

You may not qualify if:

  • Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  • No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
  • No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

RECRUITING

Pneumologie, Internistische Intensivmedizin, Beatmungsmedizin und Allgemeine Innere Medizin, Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH

Stuttgart, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Tumor tissue * 20-40 mL of peripheral blood in a heparinized (1:10) tube * 10 ml EDTA-anticoagulated blood sample

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Registries

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lars Bullinger, MD

    University Hospital of Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Bullinger, MD

CONTACT

+4973150045900Lars.Bullinger@uniklinik-ulm.de

Gerlinde Schmidtke-Schrezenmeier, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 22, 2015

First Posted

November 24, 2015

Study Start

May 1, 2014

Primary Completion

December 1, 2024

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

DE(3)