To add 36 benign control patients to the Expect study to investigate whether detection of a KRAS mutation by ddPCR in peritoneal fluid is truly specific for pancreatic cancer.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence or absence of KRAS mutation in peritoneal fluid.
Secondary outcome
-
Background summary
In patients with pancreatic ductal adenocarcinoma (PDAC), the presence of
occult peritoneal tumor cells (OPTC) at the time of resection is associated
with a worse overall and recurrence free survival. It is unclear what is the
best method to accurately diagnose OPTC in patients with PDAC. KRAS is the
predominant mutation in PDAC and present in over 90% of the patients. Digital
droplet PCR, ddPCR is, a relatively new and promising method to detect mutant
DNA. It is able to reliably detect low amounts of DNA and therefore a very
sensitive method for the detection of low abundant targets. The Expect study
has been conducted to (i) detect the presence of KRAS-mutated DNA in the
peritoneal fluid of patients with (borderline) resectable PDAC using ddPCR and
(ii) to investigate whether the presence of KRAS-mutated DNA in the peritoneal
fluid was related to the patient*s prognosis, in terms of overall survival and
disease free survival.
Study objective
To add 36 benign control patients to the Expect study to investigate whether
detection of a KRAS mutation by ddPCR in peritoneal fluid is truly specific for
pancreatic cancer.
Study design
Cohort study of 36 patients selected at the surgical outpatient clinic of OLVG.
Laparoscopic cholecystectomy and obtainment of peritoneal fluid will be carried
out in the BovenIJ Hospital. Molecular analysis of peritoneal fluid will be
carried out at the pathology department of Amsterdam UMC.
Study burden and risks
Risks are negligible and the burden minimal.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
- Indication for laparascopic cholecystectomy
- Age > 18
Exclusion criteria
A medical history of cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77048.100.21 |