NCT05754788

Brief Summary

The study aims at evaluating spatially resolved gene expression profiles of pancreatic and ampullary adenocarcinoma at favorable prognosis after surgical resection, in order to identify molecular features associated to a less aggressive biologic behavior that may benefit from upfront surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 19, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

January 10, 2023

Last Update Submit

May 25, 2023

Conditions

Resectable Pancreatic Adenocarcinoma

Keywords

resectable pancreatic adenocarcinomagene expression profileRNA sequencingprognosis of pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Favorable-prognosis gene expression pattern

    Identification of DSP gene aberrations associated to favorable prognosis (≥60-month RFS) after radical surgery for pancreatic and ampullary adenocarcinoma, through comparison of prognostically favorable and unfavorable gene expression profiles found in different tumor and microenvironment compartments.

    19/09/2022-29/09/2023

Secondary Outcomes (3)

  • TCGA comparison

    19/09/2022-29/09/2023

  • Clinical, biological and pathological factors

    19/09/2022-29/09/2023

  • External validation of gene expression profile

    19/09/2022-29/09/2023

Study Arms (2)

Favorable-prognosis pancreatic adenocarcinoma

Patients experiencing favorable prognosis (defined as RFS≥60 months) following resection for pancreatic adenocarcinoma

Unfavorable-prognosis pancreatic adenocarcinoma

Patients experiencing unfavorable prognosis (defined as RFS\<12 months) following resection for pancreatic adenocarcinoma

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A prospectively maintained database of patients with pancreatic and ampullary adenocarcinoma undergoing radical surgical resection from 1st Jan 2000 to 31st Dec 2017 in a single institution (HPB and liver transplantation Unit, National Institute of Cancer, Milan, Italy) will be used to identify patients at favorable and unfavorable prognosis.

You may qualify if:

  • Patients \>18 years old undergoing surgical treatment with curative intent for pancreatic and ampullary adenocarcinoma between 1/1/2010 and 31/12/2017 with a regular follow-up and a RFS ≥36 months including:
  • Patients with locoregional lymph node metastases found at final pathology;
  • Patients with residual microscopic disease found at final pathology (R1 resections);
  • Presence of minimal extra-regional disease not detected pre-operatively (nodule of carcinosis, single liver metastasis, single extra-regional lymph node) and removed with the primary tumor within the same intervention.

You may not qualify if:

  • Patients undergoing preoperative radiotherapy/chemotherapy for borderline resectable or initially unresectable tumors converted to surgical resection;
  • Patients with residual macroscopic disease after surgery (R1 resections);
  • Patients with metastatic disease found at laparotomy and contraindicating surgical resection, including unknown liver metastases, peritoneal carcinomatosis, distant lymph node disease;
  • Patients with unavailable follow-up or surgical samples for gene analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute of Milan

Milan, 20133, Italy

Location

Related Publications (3)

  • Torres C, Grippo PJ. Pancreatic cancer subtypes: a roadmap for precision medicine. Ann Med. 2018 Jun;50(4):277-287. doi: 10.1080/07853890.2018.1453168. Epub 2018 Mar 22.

    PMID: 29537309BACKGROUND

  • Pihlak R, Weaver JMJ, Valle JW, McNamara MG. Advances in Molecular Profiling and Categorisation of Pancreatic Adenocarcinoma and the Implications for Therapy. Cancers (Basel). 2018 Jan 12;10(1):17. doi: 10.3390/cancers10010017.

    PMID: 29329208BACKGROUND

  • Silvestris N, Brunetti O, Bittoni A, Cataldo I, Corsi D, Crippa S, D'Onofrio M, Fiore M, Giommoni E, Milella M, Pezzilli R, Vasile E, Reni M. Clinical Practice Guidelines for Diagnosis, Treatment and Follow-Up of Exocrine Pancreatic Ductal Adenocarcinoma: Evidence Evaluation and Recommendations by the Italian Association of Medical Oncology (AIOM). Cancers (Basel). 2020 Jun 24;12(6):1681. doi: 10.3390/cancers12061681.

    PMID: 32599886BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vincenzo Mazzaferro, MD PhD, University of Milan

Study Record Dates

First Submitted

January 10, 2023

First Posted

March 6, 2023

Study Start

September 19, 2022

Primary Completion

May 1, 2023

Study Completion

September 1, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

IT(1)