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Ghrelin Levels in Pancreatic Cancer Patients

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ClinicalTrials.gov Identifier: NCT00225745
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:
The primary outcome measure for this study is plasma ghrelin level.

Condition or disease Intervention/treatment
Pancreatic Cancer Procedure: Blood draw

Detailed Description:

The primary outcome measure for this study is plasma ghrelin level, and the two primary comparison are:

  • Patients with cachexia versus patients without cachexia
  • Patients with cachexia versus healthy controls

Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer
Study Start Date : April 2004
Primary Completion Date : October 2013
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1
Pancreatic cancer patients
Procedure: Blood draw
One blood draw prior to first treatment
2
Healthy controls
Procedure: Blood draw
One blood draw prior to first treatment



Primary Outcome Measures :
  1. To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls [ Time Frame: prior to treatment ]

Secondary Outcome Measures :
  1. To investigate the role of ghrelin in pathophysiology of cancer cachexia [ Time Frame: prior to treatment ]
  2. To generate hypotheses for future studies and treatment based on the findings [ Time Frame: prior to treatment ]

Biospecimen Retention:   Samples Without DNA
Whole Blood


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pancreatic cancer patients who have not received treatment. Healthy age-matched controls.
Criteria

Inclusion Criteria:

  • Histological or cytological proof of pancreatic adenocarcinoma
  • The control are will include healthy age-matched patients without cancer
  • The test arm will include patients with pancreatic cancer and they will divided into two groups: those with and without weight loss
  • Patients must have recovered from any major infections and/or surgical procedures

Exclusion Criteria:

  • Patients with other serious medical illness like congestive heart failure, thyroid disease,liver disease or renal failure - conditions that will alter their nutritional state
  • Patients on appetite stimulant and those receiving total parenteral nutrition
  • Patients who have undergone gastrectomy or those who have gastric ulcers
  • Patients receiving active chemotherapy
  • No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or for which patient has been disease free for at least five years.

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): NCT00225745


Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: J Marc Pipas, MD Dartmouth-Hitchcock Medical Center

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00225745     History of Changes
Other Study ID Numbers: DMS 0405
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: August 2015

Keywords provided by Dartmouth-Hitchcock Medical Center:
Ghrelin

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases