Pancreatic CancerNCT00225745
Ghrelin Levels in Pancreatic Cancer Patients
An observational study of Pancreatic Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The primary outcome measure for this study is plasma ghrelin level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pancreatic cancer patients who have not received treatment. Healthy age-matched controls.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
About this study
Official title: Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer
The primary outcome measure for this study is plasma ghrelin level.
Read the 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
- Conditions
- Pancreatic Cancer
- Being tested
- Blood draw
- Keywords
- Ghrelin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
One blood draw prior to first treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pancreatic cancer patients Receives: Procedure: Blood draw | |
| 2 | Healthy controls Receives: Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls
Measured: prior to treatment
Secondary outcomes (2)
To investigate the role of ghrelin in pathophysiology of cancer cachexia
Measured: prior to treatment
To generate hypotheses for future studies and treatment based on the findings
Measured: prior to treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionOct 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J Marc Pipas, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225745
- Sponsor's protocol ID
- DMS 0405
- Status last verified
- Aug 2015
- First submitted
- 22 Sep 2005
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00225745
- Acronym / sponsor ID
- DMS 0405
- Conditions
- Pancreatic Cancer
- Keywords
- Ghrelin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Oct 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary outcome measure for this study is plasma ghrelin level.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Blood drawPancreatic cancer patients |
| 2 | – | Procedure: Blood drawHealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer patients who have not received treatment. Healthy age-matched controls.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawOne blood draw prior to first treatment | Procedure or surgery | 1, 2 |
Primary outcome
To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls
Time frame: prior to treatment
2 secondary outcomes
To investigate the role of ghrelin in pathophysiology of cancer cachexia
Time frame: prior to treatment
To generate hypotheses for future studies and treatment based on the findings
Time frame: prior to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Marc Pipas, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls (time frame: prior to treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.