Chemotherapy EffectPaNLoCatNCT05514171
Prospective Registry of Patients With Pancreas Adenocarcinoma Resectable and Borderline
An observational study of Chemotherapy Effect and Pancreas Cancer, run by Hospital del Mar at 1 site in Spain.
Trial summary
Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a "snapshot" of the usual practice in our setting in terms of neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Effect, Pancreas Cancer
- What is being tested?
- Neoadyuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 31 Dec 2023
- How long will I take part?
- 3 Years
- 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: Any patient who has been diagnosed of ADK resectable or borderline and assessed in a multidiscliplinary tumor board between 2017 and 2021
Who may be able to join
- resectable or borderline pancreas ADK
- with or without radiotherapy
- any type of approach
- any type of surgery
Who cannot join
- locally advanced ADK
- No consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROSPECTIVE REGISTRY OF PATIENTS WITH BORDERLINE AND RESECTABLE PANCREATIC ADENOCARCINOMA IN CATALONIA (PaNLoCat)
Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a "snapshot" of the usual practice in our setting in terms of neoadjuvant therapy in ADK, both in terms of the different regimens used as well as the results in terms of morbidity, mortality and survival.
Likewise, in a second phase, a prospective registry of patients included in the neoadjuvant regimen for both resectable and borderline ADK diagnosed in Catalonia will be launched, which will provide us with valuable information to try to answer open questions in the context of borderline and resectable ADK treatment.
- Conditions
- Chemotherapy Effect, Pancreas Cancer
- Being tested
- Neoadyuvant therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadyuvant therapyProcedure or surgery
Patients of group neoadyuvant therapy will receive any chemotherapy treatment before surgery
| Study group | Role | What they receive |
|---|---|---|
| Neoadyuvant therapy | Patients with borderline or resectable ADK subjected to neoadyuvant therapy Receives: Procedure: Neoadyuvant therapy | |
| Upfront surgery | Patients with borderline or resectable ADK who undergo upfront surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: Three years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies 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
- 300 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Sanchez Velazquez, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514171
- Sponsor's protocol ID
- PaNLoCat_v4
- Acronym
- PaNLoCat
- Status last verified
- Jun 2024
- First submitted
- 3 Aug 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE REGISTRY OF PATIENTS WITH BORDERLINE AND RESECTABLE PANCREATIC ADENOCARCINOMA IN CATALONIA (PaNLoCat)
- ClinicalTrials.gov ID
- NCT05514171
- Acronym / sponsor ID
- PaNLoCat / PaNLoCat_v4
- Conditions
- Chemotherapy Effect, Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Aug 2022 (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.
Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a "snapshot" of the usual practice in our setting in terms of neoadjuvant therapy in ADK, both in terms of the different regimens used as well as the results in terms of morbidity, mortality and survival.
Likewise, in a second phase, a prospective registry of patients included in the neoadjuvant regimen for both resectable and borderline ADK diagnosed in Catalonia will be launched, which will provide us with valuable information to try to answer open questions in the context of borderline and resectable ADK treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadyuvant therapy | – | Procedure: Neoadyuvant therapyPatients with borderline or resectable ADK subjected to neoadyuvant therapy |
| Upfront surgery | – | –Patients with borderline or resectable ADK who undergo upfront surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who has been diagnosed of ADK resectable or borderline and assessed in a multidiscliplinary tumor board between 2017 and 2021
Key inclusion criteria (4 listed)
- resectable or borderline pancreas ADK
- with or without radiotherapy
- any type of approach
- any type of surgery
Key exclusion criteria (2 listed)
- locally advanced ADK
- No consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadyuvant therapyPatients of group neoadyuvant therapy will receive any chemotherapy treatment before surgery | Procedure or surgery | Neoadyuvant therapy |
Primary outcome
Disease free survival
Time frame: Three years follow-up
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 7 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy Effect and Pancreas Cancer, run by Hospital del Mar at 1 site in Spain.
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 2 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 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Disease free survival (time frame: Three years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2024.