Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential

NCT04323917 | Unknown

• 1 other identifier: EMT PC 1.1
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition (EMT) in biological samples, i.e. in peripheral blood samples of pancreatic cancer (PC) patients and healthy controls, to determine the presence of disease, its progression and risk of recurrence.

Conditions

Pancreatic Cancer

Keywords

Epithelial to Mesenchymal Transition; EMT; PC; mRNA; EMT-TF; Diagnosis; Biomarkers; Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• Assessments of diagnosis of PC by EMT-TF mRNA levels in blood

  To determine the stage, the remission or the progression of a pancreatic cancer in a pancreatic cancer affected subject not administered with an appropriate antitumor treatment (e.g., neo-adjuvant therapy) comprising the step of assaying a biological sample from said subject for the presence of a panel of mRNAs encoding for transcription factors involved in epithelial to mesenchymal transition.

  Analysis at day 0: at diagnosis or before surgery for PC patients; before colonoscopy in controls

Secondary Outcomes (1)

• Prediction of prognosis of PC by EMT-TF mRNA levels in blood

  Analysis at least: 7-15 days from surgery (T1), 30 days (T2) from surgery, 6 months (T3) from surgery, 1 year (T4) from surgery

Study Arms (2)

Cases

Subjects affected by Pancreatic carcinoma (PC) confirmed by tissue biopsy

Diagnostic Test: Liquid biopsy

Controls

Healthy Subject enrolled following colon cancer screening via colonoscopy

Diagnostic Test: Liquid biopsy

Interventions

Liquid biopsy DIAGNOSTIC_TEST

Detection and quantification of EMT-transcription factor mRNA levels in blood

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective pathological and molecular study of screening for pancreatic cancer. The main objectives of the trial are: 1. To develop a specific and reproducible assay for the detection pancreatic cancer based on blood RNA and to amplify cancer specific molecular markers using qPCR. 2. To correlate the presence of molecular markers in the samples with the presence of pancreatic cancer or pre-cancerous lesions. 3. To add additional biomarkers to the study panel of biomarkers. presence of colon cancer or pre-cancerous lesions. To add additional biomarkers to the study panel of biomarkers.

You may qualify if:

• Males or females over 18 years of age capable of providing informed consent.
• Pancreatic carcinoma confirmed by tissue biopsy or colon mass, clinically consistent with cancer and eventually confirmed by pathology.
• Subject were enrolled following colon cancer screening via colonoscopy

You may not qualify if:

• Patients under the age of 18 years or over the age of 80 years.
• Patients with personal history of cancer, identification of large polyp or adenomatous pathology on previous or subsequent colonoscopy
• Patient with history of abdominal surgery within the past four months
• Patients unwilling to or unable to give informed consent.
• Patients with acute inflammatory diseases or under any emergency condition.
• Pregnant women.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• IRCCS San Raffaele: collaborator

Study Sites (1)

Istituto Clinico humanitas

Milan, 20089, Italy

RECRUITING

Related Publications (1)

• Celesti G, Di Caro G, Bianchi P, Grizzi F, Basso G, Marchesi F, Doni A, Marra G, Roncalli M, Mantovani A, Malesci A, Laghi L. Presence of Twist1-positive neoplastic cells in the stroma of chromosome-unstable colorectal tumors. Gastroenterology. 2013 Sep;145(3):647-57.e15. doi: 10.1053/j.gastro.2013.05.011. Epub 2013 May 15.

  PMID: 23684708 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

mRNA from whole blood

MeSH Terms

Conditions

Pancreatic Neoplasms; Disease

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Luigi AG Laghi, MD, PhD

CONTACT

02 8224; luigi.laghi@humanitas.it

Luana Greco, MD, MSci

CONTACT

luana.greco@humanitasresearch.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: March 27, 2020
• Study Start: November 2, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)