AdenocarcinomaLAPC-NGS-A/001NCT03578939
Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma
An observational study of Adenocarcinoma, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
All patients referring to the U.O .of Digestive Endoscopy of the Humanitas Hospital to undergo EUS with biopsy in the pre-treatment evaluation of locally advanced pancreatic adenocarcinoma, satisfying all the inclusion criteria and without any of the exclusion criteria, will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Biopsy EUS guided
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 28 Feb 2021
- 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
- Adult, Older adult
Study population: All patients belonging to the U.O. of Digestive Endoscopy of the Humanitas Hospital to undergo EUS with biopsy in the pre-treatment evaluation of locally advanced pancreatic adenocarcinoma. At the time of preparation for the examination, patients will be asked for blood collection (10 ml of blood) in order to evaluate any circulating tumor cells. Patients will then be subjected to the endoscopic procedure (EUS with biopsy) provided for by good clinical practice in consideration of the suspected diagnosis for which they come to our attention.
Who may be able to join
- Age> 18 years,
- Signature of informed consent,
- Naïve patients with pancreatic adenocarcinoma (confirmed cito/ histologically), not subjected to previous treatments,
- Need to perform EUS with biopsy,
- Life expectancy over 6 months.
Who cannot join
- Patients with non-primary pancreatic tumors, pancreatic neuroendocrine tumors or benign pancreatic masses
- Patients who have already undergone cancer treatment of any kind
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Next Generation Sequencing di Cellule Tumorali Nell'Adenocarcinoma Pancreatico Localmente Avanzato
All patients referring to the U.O .of Digestive Endoscopy of the Humanitas Hospital to undergo EUS with biopsy in the pre-treatment evaluation of locally advanced pancreatic adenocarcinoma, satisfying all the inclusion criteria and without any of the exclusion criteria, will be enrolled.
Patients will then undergo endoscopic procedures (EUS with biopsy) provided by good clinical practice in consideration of the suspected diagnosis for which they come to Investigator's attention.
Read more
Biopsy will be performed using a histology needle (22 G, Acquire, Boston Scientific, MA, United States). The obtained material will be processed in the Pathological Anatomy. A small part of this will be sent to the NGS analysis.
At the time of preparation for the examination, the patients will be asked for blood collection (10 ml of blood) in order to evaluate any circulating tumor cells that will be identified by SmartBioSurface technique (Tethis S.p.A) and analyzed by appropriate molecular markers and NGS.
The clinical evaluation of the patient will take place at 6 months from the date of the procedure, through telephone contact and / or outpatient visit.
- Conditions
- Adenocarcinoma
- Being tested
- Biopsy EUS guided
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy EUS guidedProcedure or surgery
NGS Sequencing on Biopsy samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient.
Measured: 18 Months
Secondary outcomes (1)
Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jan 2017
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Carrara, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578939
- Sponsor's protocol ID
- 1890
- Acronym
- LAPC-NGS-A/001
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carrara S, Solda G, Di Leo M, Rahal D, Peano C, Giunta M, Lamonaca L, Auriemma F, Anderloni A, Fugazza A, Maselli R, Malesci A, Laghi L, Repici A. Side-by-side comparison of next-generation sequencing, cytology, and histology in diagnosing locally advanced pancreatic adenocarcinoma. Gastrointest Endosc. 2021 Mar;93(3):597-604.e5. doi: 10.1016/j.gie.2020.06.069. Epub 2020 Jul 5.
PubMed 32640200
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Sequencing di Cellule Tumorali Nell'Adenocarcinoma Pancreatico Localmente Avanzato
- ClinicalTrials.gov ID
- NCT03578939
- Acronym / sponsor ID
- LAPC-NGS-A/001 / 1890
- Conditions
- Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 6 Jul 2018 (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.
All patients referring to the U.O .of Digestive Endoscopy of the Humanitas Hospital to undergo EUS with biopsy in the pre-treatment evaluation of locally advanced pancreatic adenocarcinoma, satisfying all the inclusion criteria and without any of the exclusion criteria, will be enrolled.
Patients will then undergo endoscopic procedures (EUS with biopsy) provided by good clinical practice in consideration of the suspected diagnosis for which they come to Investigator's attention.
Biopsy will be performed using a histology needle (22 G, Acquire, Boston Scientific, MA, United States). The obtained material will be processed in the Pathological Anatomy. A small part of this will be sent to the NGS analysis.
At the time of preparation for the examination, the patients will be asked for blood collection (10 ml of blood) in order to evaluate any circulating tumor cells that will be identified by SmartBioSurface technique (Tethis S.p.A) and analyzed by appropriate molecular markers and NGS.
The clinical evaluation of the patient will take place at 6 months from the date of the procedure, through telephone contact and / or outpatient visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients belonging to the U.O. of Digestive Endoscopy of the Humanitas Hospital to undergo EUS with biopsy in the pre-treatment evaluation of locally advanced pancreatic adenocarcinoma. At the time of preparation for the examination, patients will be asked for blood collection (10 ml of blood) in order to evaluate any circulating tumor cells. Patients will then be subjected to the endoscopic procedure (EUS with biopsy) provided for by good clinical practice in consideration of the suspected diagnosis for which they come to our attention.
Key inclusion criteria (5 listed)
- Age> 18 years,
- Signature of informed consent,
- Naïve patients with pancreatic adenocarcinoma (confirmed cito/ histologically), not subjected to previous treatments,
- Need to perform EUS with biopsy,
- Life expectancy over 6 months.
Key exclusion criteria (2 listed)
- Patients with non-primary pancreatic tumors, pancreatic neuroendocrine tumors or benign pancreatic masses
- Patients who have already undergone cancer treatment of any kind
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 |
|---|---|---|
| Biopsy EUS guidedNGS Sequencing on Biopsy samples | Procedure or surgery | – |
Primary outcome
Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient.
Time frame: 18 Months
1 secondary outcome
Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis,
Time frame: 18 Months
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 Mar 2021.
- Derived from this study: PubMed 32640200Carrara S, Solda G, Di Leo M, Rahal D, Peano C, Giunta M, Lamonaca L, Auriemma F, Anderloni A, Fugazza A, Maselli R, Malesci A, Laghi L, Repici A. Side-by-side comparison of next-generation sequencing, cytology, and histology in diagnosing locally advanced pancreatic adenocarcinoma. Gastrointest Endosc. 2021 Mar;93(3):597-604.e5. doi: 10.1016/j.gie.2020.06.069. Epub 2020 Jul 5.
- Individual participant dataSharing planned: No
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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.
Silvia Carrara, MD principal investigator
Istituto Clinico Humanitas
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 Adenocarcinoma, run by Istituto Clinico Humanitas at 1 site in Italy.
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 5 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 18 Mar 2021. 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 Italy. 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?
Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient. (time frame: 18 Months). 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 NCT03578939, which also lists 1 linked publication.
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 Mar 2021.