NCT00225745

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

August 1, 2015

Enrollment Period

9.5 years

First QC Date

September 22, 2005

Last Update Submit

October 12, 2015

Conditions

Keywords

Ghrelin

Outcome Measures

Primary Outcomes (1)

  • To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls

    prior to treatment

Secondary Outcomes (2)

  • To investigate the role of ghrelin in pathophysiology of cancer cachexia

    prior to treatment

  • To generate hypotheses for future studies and treatment based on the findings

    prior to treatment

Study Arms (2)

1

Pancreatic cancer patients

Procedure: Blood draw

2

Healthy controls

Procedure: Blood draw

Interventions

Blood drawPROCEDURE

One blood draw prior to first treatment

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pancreatic cancer patients who have not received treatment. Healthy age-matched controls.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • J Marc Pipas, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

April 1, 2004

Primary Completion

October 1, 2013

Study Completion

September 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-08

Locations