Pancreatic AdenocarcinomaNCT03266757

Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma

An observational study of Pancreatic Adenocarcinoma, run by Hellenic Society of Medical Oncology.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Observational study of the Clinical Practice in patients with Borderline resectable or resectable or advanced pancreatic adenocarcinoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Adenocarcinoma
How many people: 200 participants
Where: No sites listed yet
Study dates: 11 Feb 2016to 11 Feb 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Public and Private Hospital Institutions

Who may be able to join

Patients Age 18 or older with histologically confirmed ductal pancreatic adenocarcinoma as a primary tumor
Patients with ductal pancreatic adenocarcinoma (Borderline resectable or resectable or advanced)
Patients that are alive and under treatment or follow up
Signed informed consent (ICF)

Who cannot join

Presence of other primary tumors
Pancreatic adenocarcinoma due to metastasis from other primary tumor(s)
Neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma
Patients who refuse to provide informed consent

About this study

Official title: Observational Study of the Clinical Practice in Patients With Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma in Greece

Observational study of the Clinical Practice in patients with Borderline resectable or resectable or advanced pancreatic adenocarcinoma.

Conditions: Pancreatic Adenocarcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

clinical practice-treatments
Measured: 2 years

Secondary outcomes (2)

progression Free Survival
Measured: 2 years
Overall Survival
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 201611 Feb 2018

First posted30 Aug 2017
Study start11 Feb 2016
Primary completion11 Feb 2017
Study completion11 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03266757
Sponsor's protocol ID: N/A-NI-PANC-HeSMO-005490
Status last verified: Apr 2019
First submitted: 18 Jul 2017
Last updated: 5 Apr 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Pancreatic Cancer
RecruitingPhase 3
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Solid Tumors
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic

All Pancreatic Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of the Clinical Practice in Patients With Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma in Greece
ClinicalTrials.gov ID: NCT03266757
Acronym / sponsor ID: N/A-NI-PANC-HeSMO-005490
Conditions: Pancreatic Adenocarcinoma
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Hellenic Society of Medical OncologyUniversity, hospital or other
Study start: 11 Feb 2016 (actual)
Primary completion: 11 Feb 2017 (actual)
Study completion: 11 Feb 2018 (actual)
First posted: 30 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Observational study of the Clinical Practice in patients with Borderline resectable or resectable or advanced pancreatic adenocarcinoma.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Public and Private Hospital Institutions

Key inclusion criteria (4 listed)

Patients Age 18 or older with histologically confirmed ductal pancreatic adenocarcinoma as a primary tumor
Patients with ductal pancreatic adenocarcinoma (Borderline resectable or resectable or advanced)
Patients that are alive and under treatment or follow up
Signed informed consent (ICF)

Key exclusion criteria (4 listed)

Presence of other primary tumors
Pancreatic adenocarcinoma due to metastasis from other primary tumor(s)
Neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma
Patients who refuse to provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

clinical practice-treatments
Time frame: 2 years

2 secondary outcomes

progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.

Related trials for Pancreatic Adenocarcinoma

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Pancreatic Cancer
RecruitingPhase 3
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Solid Tumors
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Adenocarcinoma, run by Hellenic Society of Medical Oncology.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical practice-treatments (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03266757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.