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Radiomics: a Study of Outcome in Lung Cancer (Radiomics)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302626
First Posted: February 24, 2011
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
H. Lee Moffitt Cancer Center and Research Institute
Policlinico Universitario Agostino Gemelli
Information provided by (Responsible Party):
Maastricht Radiation Oncology
  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:


Further study details as provided by Maastricht Radiation Oncology:

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

Enrollment: 216
Study Start Date: March 2010
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01302626


Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Italy
Gemelli Hospital Roma / Universita Cattolica del Sacre Cuore Rome
Rome, Italy
Netherlands
Maastro clinic, University Hospital of Maastricht
Maastricht, Limburg, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
H. Lee Moffitt Cancer Center and Research Institute
Policlinico Universitario Agostino Gemelli
  More Information

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01302626     History of Changes
Other Study ID Numbers: 10-4-120
First Submitted: February 22, 2011
First Posted: February 24, 2011
Last Update Posted: March 22, 2017
Last Verified: March 2017

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