Ghrelin Levels in Pancreatic Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00225745
First received: September 22, 2005
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Pancreatic Cancer
Procedure: Blood draw

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls [ Time Frame: prior to treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the role of ghrelin in pathophysiology of cancer cachexia [ Time Frame: prior to treatment ] [ Designated as safety issue: Yes ]
  • To generate hypotheses for future studies and treatment based on the findings [ Time Frame: prior to treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole Blood


Estimated Enrollment: 40
Study Start Date: April 2004
Estimated Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00225745     History of Changes
Other Study ID Numbers: DMS 0405
Study First Received: September 22, 2005
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014