RecruitingNCT02622581

Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients


Sponsor

AIO-Studien-gGmbH

Enrollment

12,400 participants

Start Date

Dec 1, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany


Eligibility

Min Age: 18 Years

Inclusion Criteria17

  • Patients who meet all of the following criteria are eligible for the project:
  • Age ≥ 18 years
  • Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments
  • Main project (Metatstatic NSCLC):
  • Confirmed non-small cell lung cancer (NSCLC)
  • Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only"
  • Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy
  • Systemic therapy or best supportive care
  • Satellite Stage I/II/III (NSCLC):
  • Confirmed non-small cell lung cancer (NSCLC)
  • Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
  • Stage I, Stage II, stage IIIA, or stage IIIB/C (UICC8)
  • Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care
  • Satellite SCLC
  • Confirmed Small cell lung cancer (SCLC)
  • Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
  • Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care

Exclusion Criteria1

  • none

Interventions

OTHERdata collection

Baseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months.


Locations(1)

Pius-Hospital

Oldenburg, Germany

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NCT02622581


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