Neuroendocrine TumorsTNE-P-KiNCT04753229
Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia
An observational study of Neuroendocrine Tumors, run by Institut Paoli-Calmettes.
Trial summary
This is a retrospective, monocentric study involving 50 patients with pancreatic neuroendocrine neoplasia resected between January 2008 and June 2020 at Paoli Calmettes Institute. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 Oct 2020
- 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: Patients who had a pre-surgical evaluation of Ki67 on micro-biopsy equipment obtained by echo-endoscopy and a resection of pancreatic neuroendocrine neoplasia by surgery at Paoli Calmettes institute between January 2008 and June 2020
Who may be able to join
- Patients with resection of pancreatic neuroendocrine neoplasia by surgery at Paoli Calmettes Institute between January 2008 and June 2020
- Patients who had a pre-surgical evaluation of Ki67 on micro-biopsy equipment obtained by echo-endoscopy.
Who cannot join
- Patient with a mixed tumor of the pancreas.
- Patient with a pancreas tumor composed of several nodules of similar size without a main mass and for which it is not possible to determine the biopsied nodule during echo-endoscopy.
- Initial micro-biopsy in a private pathology laboratory
- Initial subechoendoscopic puncture cytology only (Ki67 not possible)
- No initial micro-biopsy and surgery
About this study
Official title: Comparison of the Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia Between Preoperative Micro-biopsies and Surgical Specimens
This is a retrospective, monocentric study involving 50 patients with pancreatic neuroendocrine neoplasia resected between January 2008 and June 2020 at Paoli Calmettes Institute.
The primary objective of the study is to evaluate the grade concordance rate, based on Ki67 obtained on the pre-operative micro-biopsy and the surgical specimen.
Read more
Based on the histology slides obtained in the course of the treatment, several Ki67 recounts will be performed on pre-operative tumor micro-biopsies and on tumors resected after surgery:
- a manual count (on photo printed in the hotspot area according to World Health Organization (WHO) 2017 recommendations, by an expert pathologist and a junior pathologist.
- Automated counting using specific software based on artificial intelligence (Qpath software).
On the other hand, clinical, surgical and anatomopathological data will be collected in order to follow the patient evolution.
- Conditions
- Neuroendocrine Tumors
- Keywords
- pancreatic neuroendocrine tumor, Ki67, artificial intelligency
- Medical subject headings
- Neuroendocrine Tumors, Adenoma, Islet Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki67 Grade
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
Measured: on pre-operative micro-biopsies
Ki67 Grade
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
Measured: on surgical specimens
Secondary outcomes (4)
Percentage of Ki67 positive cells on total counted cells
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
Measured: on preoperative micro-biopsies
Percentage of Ki67 positive cells on total counted cells
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
Measured: on surgical specimens
Percentage of Ki67 positive cells on total counted cells
Evaluation by digital pathology before and after machine learning
Measured: on preoperative micro-biopsies
Percentage of Ki67 positive cells on total counted cells
Evaluation by digital pathology before and after machine learning
Measured: on surgical specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jan 2008
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flora Poizat, Principal investigator, Institut Paoli-Calmettes (IPC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753229
- Sponsor's protocol ID
- TNE P Ki-IPC 2020-046
- Acronym
- TNE-P-Ki
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ki67 Proliferation Index of Pancreatic Neuroendocrine Neoplasia Between Preoperative Micro-biopsies and Surgical Specimens
- ClinicalTrials.gov ID
- NCT04753229
- Acronym / sponsor ID
- TNE-P-Ki / TNE P Ki-IPC 2020-046
- Conditions
- Neuroendocrine Tumors
- Keywords
- pancreatic neuroendocrine tumor, Ki67, artificial intelligency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 15 Feb 2021 (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.
This is a retrospective, monocentric study involving 50 patients with pancreatic neuroendocrine neoplasia resected between January 2008 and June 2020 at Paoli Calmettes Institute.
The primary objective of the study is to evaluate the grade concordance rate, based on Ki67 obtained on the pre-operative micro-biopsy and the surgical specimen.
Based on the histology slides obtained in the course of the treatment, several Ki67 recounts will be performed on pre-operative tumor micro-biopsies and on tumors resected after surgery:
- a manual count (on photo printed in the hotspot area according to World Health Organization (WHO) 2017 recommendations, by an expert pathologist and a junior pathologist.
- Automated counting using specific software based on artificial intelligence (Qpath software).
On the other hand, clinical, surgical and anatomopathological data will be collected in order to follow the patient evolution.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a pre-surgical evaluation of Ki67 on micro-biopsy equipment obtained by echo-endoscopy and a resection of pancreatic neuroendocrine neoplasia by surgery at Paoli Calmettes institute between January 2008 and June 2020
Key inclusion criteria (2 listed)
- Patients with resection of pancreatic neuroendocrine neoplasia by surgery at Paoli Calmettes Institute between January 2008 and June 2020
- Patients who had a pre-surgical evaluation of Ki67 on micro-biopsy equipment obtained by echo-endoscopy.
Key exclusion criteria (5 listed)
- Patient with a mixed tumor of the pancreas.
- Patient with a pancreas tumor composed of several nodules of similar size without a main mass and for which it is not possible to determine the biopsied nodule during echo-endoscopy.
- Initial micro-biopsy in a private pathology laboratory
- Initial subechoendoscopic puncture cytology only (Ki67 not possible)
- No initial micro-biopsy and surgery
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
Ki67 Grade
Time frame: on pre-operative micro-biopsies
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
Ki67 Grade
Time frame: on surgical specimens
Evaluation by a pathologist by manual counting according to WHO 2017 recommendations
4 secondary outcomes
Percentage of Ki67 positive cells on total counted cells
Time frame: on preoperative micro-biopsies
Percentage of Ki67 positive cells on total counted cells
Time frame: on surgical specimens
Percentage of Ki67 positive cells on total counted cells
Time frame: on preoperative micro-biopsies
Percentage of Ki67 positive cells on total counted cells
Time frame: on surgical specimens
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 18 Feb 2021.
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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.
Flora Poizat principal investigator
Institut Paoli-Calmettes (IPC)
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Institut Paoli-Calmettes.
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 2 inclusion and 5 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 18 Feb 2021. 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?
Ki67 Grade (time frame: on pre-operative micro-biopsies). The study lists 2 primary outcomes in all. 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 18 Feb 2021.