Biobank Carcinoma: Storing Blood and Protein of Patients With Cancer (Biobank)
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01084785 |
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Recruitment Status :
Recruiting
First Posted : March 11, 2010
Last Update Posted : March 13, 2024
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Sponsor:
Maastricht Radiation Oncology
Collaborator:
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht Radiation Oncology
| Tracking Information | |||||||||
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| First Submitted Date | March 10, 2010 | ||||||||
| First Posted Date | March 11, 2010 | ||||||||
| Last Update Posted Date | March 13, 2024 | ||||||||
| Study Start Date | January 2003 | ||||||||
| Estimated Primary Completion Date | January 2026 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures | Not Provided | ||||||||
| Original Primary Outcome Measures | Not Provided | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Biobank Carcinoma: Storing Blood and Protein of Patients With Cancer | ||||||||
| Official Title | 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. | ||||||||
| 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | 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 | ||||||||
| Condition | Cancer | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | 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. doi: 10.1016/j.ijrobp.2010.06.011. 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 | Recruiting | ||||||||
| Estimated Enrollment |
10000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 2026 | ||||||||
| Estimated Primary Completion Date | January 2026 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Netherlands | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT01084785 | ||||||||
| Other Study ID Numbers | 08-06-23/01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Maastricht Radiation Oncology | ||||||||
| Original Responsible Party | Maastricht Radiation Oncology, Maastricht University Medical Center | ||||||||
| Current Study Sponsor | Maastricht Radiation Oncology | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Maastricht University Medical Center | ||||||||
| Investigators |
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| PRS Account | Maastricht Radiation Oncology | ||||||||
| Verification Date | April 2022 | ||||||||