Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer.

NCT02078245 | Unknown

• 1 other identifier: 2010/1001-32
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a positive impact in survival for patients with an increased genetic risk to develop pancreas cancer. In this study, following the indication of the swedish guidelines, consecutive patients with a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance Imaging (MRI) based. The results of this study were analyzed looking in the patients files collected during the screening period.

Conditions

Hereditary Pancreatitis; Hereditary Pancreatic Cancer

Keywords

Familial pancreatic cancer; Surveillance; Screening

Outcome Measures

Primary Outcomes (1)

• MRI accuracy

  MRI accuracy in detection precancerous pancreatic lesions.

  Three years

Secondary Outcomes (2)

• Definition of spectrum of precancerous pancreatic lesions

  During three years

• Outcome of surveillance program

  Three years

Study Arms (1)

Familial pancreatic cancer patients

Individual with ten fold higher risk to develop pancreatic cancer.

Other: MRI

Interventions

MRI OTHER

MRI

Familial pancreatic cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Familial risk for pancreatic cancer

You may qualify if:

• fold higher risk to develop pancreatic cancer
• Obtained informed consent

You may not qualify if:

• age less than 18 yrs
• No consensus obtained

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Gastrocentrum Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

Related Publications (6)

• Canto MI, Harinck F, Hruban RH, Offerhaus GJ, Poley JW, Kamel I, Nio Y, Schulick RS, Bassi C, Kluijt I, Levy MJ, Chak A, Fockens P, Goggins M, Bruno M; International Cancer of Pancreas Screening (CAPS) Consortium. International Cancer of the Pancreas Screening (CAPS) Consortium summit on the management of patients with increased risk for familial pancreatic cancer. Gut. 2013 Mar;62(3):339-47. doi: 10.1136/gutjnl-2012-303108. Epub 2012 Nov 7.

  PMID: 23135763 BACKGROUND

• Bartsch DK, Dietzel K, Bargello M, Matthaei E, Kloeppel G, Esposito I, Heverhagen JT, Gress TM, Slater EP, Langer P. Multiple small "imaging" branch-duct type intraductal papillary mucinous neoplasms (IPMNs) in familial pancreatic cancer: indicator for concomitant high grade pancreatic intraepithelial neoplasia? Fam Cancer. 2013 Mar;12(1):89-96. doi: 10.1007/s10689-012-9582-y.

  PMID: 23179793 BACKGROUND

• Pozzi Mucelli RM, Moro CF, Del Chiaro M, Valente R, Blomqvist L, Papanikolaou N, Lohr JM, Kartalis N. Branch-duct intraductal papillary mucinous neoplasm (IPMN): Are cyst volumetry and other novel imaging features able to improve malignancy prediction compared to well-established resection criteria? Eur Radiol. 2022 Aug;32(8):5144-5155. doi: 10.1007/s00330-022-08650-5. Epub 2022 Mar 11.

  PMID: 35275259 RESULT

• Del Chiaro M, Ateeb Z, Hansson MR, Rangelova E, Segersvard R, Kartalis N, Ansorge C, Lohr MJ, Arnelo U, Verbeke C. Survival Analysis and Risk for Progression of Intraductal Papillary Mucinous Neoplasia of the Pancreas (IPMN) Under Surveillance: A Single-Institution Experience. Ann Surg Oncol. 2017 Apr;24(4):1120-1126. doi: 10.1245/s10434-016-5661-x. Epub 2016 Nov 7.

  PMID: 27822633 RESULT

• Capurso G, Signoretti M, Valente R, Arnelo U, Lohr M, Poley JW, Delle Fave G, Del Chiaro M. Methods and outcomes of screening for pancreatic adenocarcinoma in high-risk individuals. World J Gastrointest Endosc. 2015 Jul 25;7(9):833-42. doi: 10.4253/wjge.v7.i9.833.

  PMID: 26240684 RESULT

• Del Chiaro M, Verbeke CS, Kartalis N, Pozzi Mucelli R, Gustafsson P, Hansson J, Haas SL, Segersvard R, Andren-Sandberg A, Lohr JM. Short-term Results of a Magnetic Resonance Imaging-Based Swedish Screening Program for Individuals at Risk for Pancreatic Cancer. JAMA Surg. 2015 Jun;150(6):512-8. doi: 10.1001/jamasurg.2014.3852.

  PMID: 25853369 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Bloodsamples

MeSH Terms

Conditions

Hereditary pancreatitis; Pancreatic carcinoma, familial

Study Officials

• Marco del Chiaro, ass. prof.

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Löhr, Professor

CONTACT

+46 8-585800000; matthias.lohr@ki.se

Marco del Chiaro, Ass prof.

CONTACT

+46 8-585800000; marco.del-chiaro@karolinska.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: March 5, 2014
• Study Start: August 1, 2010
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

SE (1)