Biobank Carcinoma: Storing Blood and Protein of Patients With Cancer
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| First Received Date ICMJE | March 10, 2010 | ||||||||
| Last Updated Date | December 27, 2012 | ||||||||
| Start Date ICMJE | January 2003 | ||||||||
| Estimated Primary Completion Date | January 2025 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01084785 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Biobank Carcinoma: Storing Blood and Protein of Patients With Cancer | ||||||||
| Official Title ICMJE | Storing Blood for Analysis of DNA and Protein of Patients With Cancer in MAASTRO Clinic | ||||||||
| Brief Summary | The purpose of this study is to determine, by means of DNA and protein analysis, the relationship between DNA and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects. |
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| Detailed Description | It has already been known for a long time that cancer is a genetic disorder and that the development of the illness is a very complex interaction between genetic and surrounding factors. Also the response on therapy and the development and seriousness of side effects is stipulated by this complicated collaboration of genetic and surrounding factors. Moreover it is not only the DNA that plays an important role but also the systems of control at protein level. At this moment a lot of questions remain to be answered because up till now the studies were of rather restricted statistic strength with frequently inconsistent dates and moreover retrospective. Major retrospective studies are necessary to distinguish the relationship between DNA/protein patterns and clinical relevant endpoints like prognosis and toxicity in which an as broad as possible patient group is being monitored. For this reason we want to take blood samples in MAASTRO clinic of all patients with lung cancer and to store it encrypted so that we can perform DNA and protein analyses in future and to correlate the results with survival and toxicity of the treatment. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | primary care clinic |
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| Condition ICMJE | Cancer | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, van der Weide H, Rao B, Lambin P. Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-8. Epub 2010 Oct 1. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10000 | ||||||||
| Estimated Completion Date | January 2025 | ||||||||
| Estimated Primary Completion Date | January 2025 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01084785 | ||||||||
| Other Study ID Numbers ICMJE | 08-06-23/01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Maastricht Radiation Oncology | ||||||||
| Study Sponsor ICMJE | Maastricht Radiation Oncology | ||||||||
| Collaborators ICMJE | Maastricht University Medical Center | ||||||||
| Investigators ICMJE |
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| Information Provided By | Maastricht Radiation Oncology | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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