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OpenTrials
Completed

NCT Number: NCT00296114

Pancreatic Cancer Serum and DNA Repository

To prospectively collect serum and DNA samples from subjects with pancreatic cancer, pancreatitis, liver disease, and from healthy and at-risk volunteers in order to identify novel biomarkers for early diagnosis, differential diagnosis, stage, natural history of the disease, response to treatment, and to identify novel targets for therapeutic interventions. In particular:

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital (12 De Octubre), Madrid, Spain

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About this study

  • To establish a central pancreatic cancer specimen repository to serve as a resource for current and future scientific studies.
  • To utilize the PCRT clinical data base to perform clinicopathologic correlation with the results of those studies.
  • To test new hypotheses as they emerge.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion criteria

4.1 At the time of subject registration, CRAB will verify the institution's IRB date to ensure that the subject can be enrolled.

4.2 Potential study participants must meet the eligibility criteria found in Section 12.0 (Eligibility Checklist). Candidates will fall into one of four groups:

  • Pancreatic cancer patients;
  • Pancreatic and Liver Disease patients;
  • Healthy, At-Risk Volunteers (smoker, (defined as individuals who have smoked >= 100 cigarettes in their lifetime, and who currently smoke every day or some days [MMWR November 12, 2004, 53(44);1035-1037]), diabetic, and/or family history); and
  • Healthy Volunteers (no history of cancer). The Eligibility Checklist must be photocopied, completed and stored on site. Eligibility is confirmed during registration, by answering yes to the question, Have all eligibility criteria been met? on the Registration Form.

Eligibility Checklist:

  • Pancreatic Cancer Patient Criteria All subjects, regardless of gender and ethnicity are eligible for this study Pathological diagnosis of pancreatic malignant neoplasm Expected availability of clinical follow up data Eighteen years old or older All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
  • Pancreatitis and Liver Disease Subject Criteria All subjects, regardless of gender and ethnicity are eligible for this study Pathological diagnosis of pancreatitis or liver disease Eighteen years old or older All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
  • Healthy, At-Risk Volunteers All subjects, regardless of gender and ethnicity are eligible for this study Is a smoker, is diabetic AND/OR has a family history of pancreatic cancer Eighteen years old or older with no history of cancer All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
  • Healthy Volunteers (no at-risk factors) All subjects, regardless of gender and ethnicity are eligible for this study Eighteen years old or older with no history of cancer All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines

Treatment and study plan

Serum and DNA Samples

Procedure

To collect serum and DNA samples from subjects

Sponsors and collaborators

Lead sponsor

Pancreatic Cancer Research Team

Other

Registry information

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Feb 24, 2006
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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