The Cancer of the Pancreas Screening-5 CAPS5)Study

What Was Tested

In this phase 3 trial, researchers set out to test Secretin.

The Sub Investigator at each site will be responsible for internal monitoring at their site.

It had nine arms (groups): one (active comparator), Group 1 germline mutation carrier (active comparator), Group 2 germline mutation carrier (active comparator), Hereditary pancreatitis (active comparator) and Peutz-Jeghers Syndrome (active comparator).

The registry classes the interventions as diagnostic test, drug and other.

More on the Plan

The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.

Who Took Part

9000 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Hereditary Pancreatitis or. Peutz-Jeghers Syndrome or. Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR. Endoscopic evaluation of pancreas scheduled.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: medical comorbidities or coagulopathy that contraindicate endoscopy; stricture or obstruction in the upper gi tract that does not allow passage of the echoendoscope; poor performance status.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label Secretin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-01-06 with completion listed for 2028-12.

It ran at 9 sites in United States (9).

Its stated primary purpose is diagnostic.

What Was Measured

It also tracked 1 secondary outcome, for example Compare pancreas juice with pancreas cyst fluid.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Secretin in 9000 people.

With 9000 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.