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Trial record 12 of 16 for:    "Peutz-Jeghers Syndrome"

Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00587132
Recruitment Status : Terminated (Lack of funding)
First Posted : January 7, 2008
Results First Posted : June 20, 2013
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Naoki Takahashi, Mayo Clinic

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Pancreatic Cancer
Intervention Drug: Synthetic Human Secretin
Enrollment 4
Recruitment Details Subjects were recruited from the Mayo Clinic in Rochester, Minnesota from November 2006 until April 2009.
Pre-assignment Details  
Arm/Group Title New Onset Diabetes Familial Pancreatic Cancer Peutz-Jeghers Syndrome Clinical Symptoms of Pancreatic Cancer, Normal CT
Hide Arm/Group Description

Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Adults age 35-99 with Peutz-Jeghers syndrome.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
Period Title: Overall Study
Started 4 0 0 0
Completed 4 0 0 0
Not Completed 0 0 0 0
Arm/Group Title New Onset Diabetes Familial Pancreatic Cancer Peutz-Jeghers Syndrome Clinical Symptoms of Pancreatic Cancer, Normal CT Total
Hide Arm/Group Description

10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

10 adults age 35-99 with Peutz-Jeghers syndrome.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 4 0 0 0 4
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 0 participants 0 participants 4 participants
<=18 years 0 0
Between 18 and 65 years 2 2
>=65 years 2 2
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 0 participants 0 participants 4 participants
Female 3 3
Male 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 0 participants 0 participants 0 participants 4 participants
4 4
1.Primary Outcome
Title Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.
Hide Description Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.
Time Frame Day 1 of study
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.
Arm/Group Title New Onset Diabetes Familial Pancreatic Cancer Peutz-Jeghers Syndrome Clinical Symptoms of Pancreatic Cancer, Normal CT
Hide Arm/Group Description:

Adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Adults age 35-99 with Peutz-Jeghers syndrome.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Overall Number of Participants Analyzed 4 0 0 0
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title New Onset Diabetes Familial Pancreatic Cancer Peutz-Jeghers Syndrome Clinical Symptoms of Pancreatic Cancer, Normal CT
Hide Arm/Group Description

10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

10 adults age 35-99 with Peutz-Jeghers syndrome.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
All-Cause Mortality
New Onset Diabetes Familial Pancreatic Cancer Peutz-Jeghers Syndrome Clinical Symptoms of Pancreatic Cancer, Normal CT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
New Onset Diabetes Familial Pancreatic Cancer Peutz-Jeghers Syndrome Clinical Symptoms of Pancreatic Cancer, Normal CT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
New Onset Diabetes Familial Pancreatic Cancer Peutz-Jeghers Syndrome Clinical Symptoms of Pancreatic Cancer, Normal CT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0   0/0   0/0 
The study was terminated early due to lack of funding.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Naoki Takahashi
Organization: Mayo Clinic
Phone: 507-284-7249
Responsible Party: Naoki Takahashi, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587132     History of Changes
Other Study ID Numbers: 231-06
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: April 29, 2013
Results First Posted: June 20, 2013
Last Update Posted: June 24, 2013