NCT04099134

Brief Summary

PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Oct 2018Oct 2029

Study Start

First participant enrolled

October 10, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

10 years

First QC Date

September 18, 2019

Last Update Submit

September 23, 2019

Conditions

Pancreas AdenocarcinomaPancreas Cancer

Outcome Measures

Primary Outcomes (2)

  • General assessment of applied therapy modalities in pancreatic cancer

    First diagnose to death or end of surveillance (5 years after curative resection)

  • Quality of life in pancreatic cancer patients

    EORTC QLQ c30 and PAN 26

    First diagnose to death or end of surveillance (5 years after curative resection)

Secondary Outcomes (3)

  • General epidemiologic assessment

    First diagnose to death or end of surveillance (5 years after curative resection)

  • Assessment of tumor surveillance in pancreatic cancer patients

    First diagnose to death or end of surveillance (5 years after curative resection)

  • Evaluation of predictive and prognostic markers

    First diagnose to death or end of surveillance (5 years after curative resection)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult newly diagnosed patients with a PDAC could be included in the registry trial.

You may qualify if:

  • Treatment naive histologically or cytologically proven pancreatic ductal adenocarcinoma (PDAC) or highly suspicious diagnosis (only pre-curative-intended resection)
  • Age =\>18 years
  • written informed consent

You may not qualify if:

  • papillary cancer
  • neuroendocrine pancreatic tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Ulm

Ulm, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Tumor tissue from biopsies or surgery * Blood samples at defined timepoints

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Thomas Seufferlein, MD

    Ulm University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Seufferlein, MD

CONTACT

+49 731 50044501thomas.seufferlein@uniklinik-ulm.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department for internal medicine I

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 23, 2019

Study Start

October 10, 2018

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

DE(1)