MDACC Study Summary 2007-0193

Study Summary
No. 2007-0193:.......Pancreas......Jeffrey H. Lee......Gastroenterology/Hepatology and Nutrition

Study Summary Title



Study Summary Number:	2007-0193

Study Title:	SCREENING FOR EARLY PANCREATIC NEOPLASIA IN HIGH RISK INDIVIDUALS: THE LUSTGARTEN FOUNDATION-NCI SPORE CANCER OF THE PANCREAS SCREENING STUDY (CAPS 3)

Physician

New Patient Referral



Name:	Jeffrey H. Lee	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gastroenterology/Hepatology and Nutrition	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5073 Contact us about clinical trials

General Information



Disease Group:	Pancreas	Supported By:	THE LUSTGARTEN FOUNDATION-NCI SPORE CANCER OF THE PANCREAS SCREENING STUDY

Phase of Study:	N/A	Return Visit:	Study participants will not return to MDACC for study visits. All of the patient follow-up will be standard of care. One study follow-up phone call will be made to the patients.

Treatment Agents:	None	Home Care:	No treatment will be given or available at home

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Participation in this study will increase the length or frequency of hospitalization for the subjects.


Description/ Intervention:	The goal of this clinical research study is to see if pancreatic cancer can be found before any signs or symptoms of the disease are shown.

Study Objectives / Outcomes

Primary Specific Aim
1. To determine the diagnostic yield of screening high risk patients (defined as relatives of patients with familial pancreatic cancer,patients with familial Peutz-Jeghers syndrome, and patients with germline BRCA2 and p16 mutations) for early pancreatic neoplasia using endoscopic ultrasonography, CT, and MRI/MRCP.

Secondary Specific Aims
2. To determine the prevalence and stage of early pancreatic cancer and precursor lesions in asymptomatic persons and the potential diagnostic yield of a screening program for high risk patients. To estimate the relative risk for pancreatic neoplasia adjusted for confounding factors.
3. To describe the EUS abnormalities and the phenotype of pancreatic cancer in high risk individuals. To determine the reliability (interobserver variation) of EUS, CT, and MRI/MRCP for assessment of specific abnormalities. To correlate the EUS, CT, and MRI/MRCP and histologic abnormalities, determine EUS, CT, and MRI/MRCP accuracy for diagnosis of pancreatic neoplasia (using cytology/histology as the gold standard), and create a scoring system for grading the severity of these EUS, CT, and MRI/MRCP changes that can be validated in future studies.
4. To explore the potential predictive value of a newly-developed Mendelian risk prediction model (PANCPRO 1) for improving the identification of individuals with an increased risk of developing pancreatic cancer who might benefit from screening, as compared with simple measures from family history (such as number of affected relatives).
5. To validate a panel of recently identified candidate DNA and protein markers in pancreatic juice and serum as indicators of prevalent neoplasms in high risk individuals, as compared to individuals with normal pancreas, chronic pancreatitis, intraductal papillary mucinous neoplasms (IPMNs), and pancreatic ductal adenocarcinoma without a family history of pancreatic cancer.
6. a) To determine the effect of genetic counseling and screening for pancreas cancer on quality of life, cancer-specific worry, and patient perception of risk of other malignancies genetically associated with pancreas cancer; b) To compare baseline quality of life of high risk individuals with controls; c) To determine patient perception of the value of genetic counseling for hereditary pancreas cancer.

Study Status Information



Study Activation / Registration Date:	03/04/2008

IRB Review and Approval Date:	09/25/2007

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	1000

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) High Risk Group 1 (familial pancreatic cancer relatives): a. Age >/= 40 years old (or 10 years younger than the age of youngest relative with pancreatic cancer) and < 80 years old, AND b. No prior screening of the pancreas with EUS, dedicated pancreatic protocol CT, or MRI/MRCP within 3 years, AND c. Member of a family with 2 or more blood relatives with a history of pancreatic cancer and have a first-degree relationship (parent, sibling, or child) with at least one of the relatives with pathologically- proven pancreatic cancer

2) If only 2 family members are affected, then both must have had pancreatic cancer and a first-degree relationship with the individual being screened.

3) If there are more than 2 affected family members on the same side of the family, at least 1 of these must have a first-degree relationship with the individual being screened, and the affected first degree relative must have either a pancreatic cancer or a pathologically-proven precursor lesion such as an intraductal papillary mucinous neoplasm (IPMN) or multi-focal PanIN 3 detected by screening.

4) High Risk Group 1 (familial Peutz-Jeghers syndrome): a. Age >/= 30 years old and < 80 years old, AND, b. No prior screening of the pancreas with EUS, dedicated pancreatic protocol CT, or MRI/MRCP within 3 years, AND c. Characteristic intestinal hamartomatous polyps, or mucocutaneous melanin deposition, or, known STK-11 germline mutation

5) High Risk Group 3 (mutation carriers): a. Age >/= 40 years old and < 80 years old, AND b. No prior screening of the pancreas with EUS, dedicated pancreatic protocol CT, or MRI/MRCP within 3 years, AND, c. Patient is carrier of a known BRCA2 or FAMMM (p16/CDKN2A) mutation, or hereditary nonpolyposis colorectal cancer (HNPCC) mutation, AND d. There is >/= 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.

6) All persons with known genetic mutation must have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory.

7) A good faith attempt should be made to confirm pancreatic cancers in the family members via registration in a pancreatic cancer registry

8) The affected first degree relative of the person being screened must be confirmed by medical record or death certificate.

Exclusion Criteria:

1) History of pancreatic cancer, previously diagnosed pancreatic mass or cyst, or previous pancreas surgery

2) Any suspicion of pancreatic disease, based on clinical history (symptoms of possible pancreas problems: > 5 pound unintentional weight loss in the past 6 months, undiagnosed upper abdominal pain, loss of appetite, jaundice in the past 6 months, serum CA19-9 > 2 times the upper of normal (if checked within the past year by the patient's physician), physical examination (jaundice, cachexia), and/or imaging studies (pancreatic enlargement, mass or cyst, pancreatic duct dilation or stricture, pancreatic inflammation or atrophy)

3) Subjects will not be enrolled if they feel that they would not be interested in trreatment of pancreatic abnormalities found during this study, such as possible pancreas surgery

4) Medical illnesses that increase the risk of endoscopy and possible surgery: unstable angina, congestive heart failure requiring daily medication, chronic obstructive pulmonary disease (COPD or emphysema) requiring daily medication, pulmonary hypertension, obstructive sleep apnea requiring treatment with BIPAP or CPAP.

5) History of chronic kidney disease, serum creatinine > 1.8 mg/dl or estimated glomerulofiltration rate (eGFR) <30 ml/min, ongoing acute renal failure, cirrhosis of the liver, chronic hepatitis

6) History of moderate (generalized hives) or severe (facial swelling, airway reaction) reacation to intravenous radiographic contrast material. Subjects with a history of prior mild reaction to intravenous contrast (several hives) can be enrolled, but will be premedicated prior to CT scan with methylprednisolone 32 mg orally 12 hours and 2 hours prior to CT, as well as benadryl 50 mg orally one hour prior to CT.

7) Karnosfky performance status of < 60.

8) Partial or complete resection of their pancreas

9) History of obstruction in the upper GI tract such as esophageal or phyloric stricture, which causes difficulty swallowing or did not allow passage of an endoscope. Subjects who have been previously treated for a Schatzki's ring and currently have no difficulty swallowing may be enrolled.

10) Bleeding diathesis (clotting problems) or a history of thrombocytopenia (low platelet count)

11) Previous gastric or biliary surgery other than cholecystectomy

12) Cancer (other than basal cell of the skin) within last 5 years not in remission.

13) History of AIDS/HIV infection

14) Inability to provide informed consent

15) Pregnancy

16) Morbid obesity with body weight > 350 pounds

17) History of metallic implants such as aneurysm clips, prosthetic joints, prosthetic valvves, pacemakers, defibrillators, or other contraindication to MRI

18) Dementia

19) Claustrophobia

Links

Registration Number: NCT00438906
Study Information on Clinical Trials Registry (clinicaltrials.gov)