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Radiomics: a Study of Outcome in Lung Cancer

This study is currently recruiting participants.
Verified July 2012 by Maastricht Radiation Oncology
Sponsor:
Collaborators:
H. Lee Moffitt Cancer Center and Research Institute
Gemelli Hospital Roma
Information provided by (Responsible Party):
Iverna, Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01302626
First received: February 22, 2011
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

Aim of the study: The main aim is to collect data of patients with lung cancer, and to perform different analyses on this data. The data contains information on patient and tumor characteristics, imaging, and treatment characteristics. With this data it is possible to improve and validate the predictive model for survival and long term toxicity in lung cancer by multicentric prospective data collection. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive models validated in this study.

Hypothesis: The general hypothesis is that we get a better prediction in terms of AUC (area under the curve) of survival and long term toxicity when we combine multifactorial variables. These variables consist of information from clinical data, imaging data, data related to treatment type and treatment quality.


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiomics: a Prospective Study of Outcome in Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Maastricht Radiation Oncology:

Biospecimen Retention:   Samples With DNA
  • Lung tumor tissue
  • Lung normal tissue

Estimated Enrollment: 216
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Groups/Cohorts
1: Surgery alone or combined with (chemo)radiotherapy
  • Fresh frozen tumor tissue and normal tissue;
  • Recording of clinical characteristics, imaging, surgery features.

After treatment: FU at 2-3 weeks post surgery, 3,6,12,24 and 36 months post-surgery
2: Radiotherapy alone

(including stereotactic radiotherapy)

  • Before start RT (during staging):Optional: Biopsies, frozen or RNA later, of tumor and/or lymph nodes;
  • Day 0 (before start RT): Recording of clinical characteristics, imaging, and radiotherapy features;
  • Day 8-12 (during RT): Scoring of toxicity.

After treatment: FU at 2-3 weeks post RT, 3,6,12,24 and 36 months post-RT
3: Sequential chemotherapy and radiotherapy

  • Day -30 (before start CT):

    • Optional: Biopsies, frozen or RNA later, of tumor and/or lymph nodes;
    • Recording of clinical characteristics, imaging, and chemotherapy features.

  • Day 0 (before start RT):

    • Recording of clinical characteristics, imaging, and radiotherapy features.
    • Scoring of toxicity.

  • Day 8-12 (during RT):

    • Scoring of toxicity.

After treatment: FU at 2-3 weeks post RT, 3,6,12,24 and 36 months post-RT
4: Concurrent chemoradiotherapy with induction chemotherapy

  • Day -30 until-18 (before start CT):

    • Optional: Biopsies, frozen or RNA later, of tumor and/or lymph nodes;
    • Recording of clinical characteristics, imaging, and chemotherapy features.

  • Day 0 (before start RT):

    • Recording of clinical characteristics, imaging, and radiotherapy features.
    • Scoring of toxicity.

  • Day 8-12 (during RT):

    • Scoring of toxicity.

After treatment: FU at 2-3 weeks post RT, 3,6,12,24 and 36 months post-RT
5: Concurrent chemoradiotherapy without induction chemotherapy

  • Day 0 (before start CRT):

    • Optional: Biopsies, frozen or RNA later, of tumor and/or lymph nodes;
    • Recording of clinical characteristics, imaging, chemotherapy features, and radiotherapy features.

  • Day 8-12 (during CRT):

    • Scoring of toxicity.

After treatment: FU at 2-3 weeks post RT, 3,6,12,24 and 36 months post-RT
6: Stage IV lungcancer, any systemic therapy & supportive care

Day 0:

  • Optional: Biopsies, frozen or RNA later, of tumor and/or lymph nodes;
  • Recording of clinical characteristics, imaging, surgery or any systemic (MoAb) features.

After treatment: FU at 2-3 weeks post treatment, 3,6,12,24 and 36 months post-treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with lung cancer

Criteria

Inclusion Criteria:

  • Histological or cytological proven lung cancer (small cell or non-small cell);
  • 18 years or older;
  • Informed consent according to national rules (US: written informed consent, NL: no objection rule)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302626

Contacts
Contact: Iverna R. Nijsten, M.Sc. +31(0)88 44 55 666 ext 867 iverna.nijsten@maastro.nl

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Robert A Gatenby, M.D.         Robert.Gatenby@moffitt.org    
Contact: Robert J Gillies, Ph.D.         Robert.Gillies@moffitt.org    
Italy
Gemelli Hospital Roma / Universita Cattolica del Sacre Cuore Rome Recruiting
Rome, Italy
Contact: Vincenzo Valentini, M.D.         vvalentini.it@email.it    
Contact: Elisa Meldolesi, M.D.         elimlds@gmail.com    
Netherlands
Maastro clinic, University Hospital of Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6229 ET
Contact: Iverna R. Nijsten, M.Sc.     +31(0)88 44 55 666 ext 867     iverna.nijsten@maastro.nl    
Sponsors and Collaborators
Maastricht Radiation Oncology
H. Lee Moffitt Cancer Center and Research Institute
Gemelli Hospital Roma
  More Information

No publications provided

Responsible Party: Iverna, Sr. Datamanager, Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01302626     History of Changes
Other Study ID Numbers: 10-4-120
Study First Received: February 22, 2011
Last Updated: July 17, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht Radiation Oncology:
NSCLC
SCLC
lung cancer
RNA
DNA
 imaging
genomics
proteomics
predictive model
prospective study

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013