Circulating Tumor DNA as Surgical Biomarker in Patients W... | NCT05853198

Studies
Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability

NCT05853198

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Status

Unknown status

Last Update Posted

May 10, 2023Actual

Enrollment

165Estimated

Phase

Not Applicable

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Interventions

ctDNA analysis

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 29, 2022Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Apr 18, 2023

First Submission Date that Met QC Criteria

May 8, 2023

First Posted Date

May 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2023

Last Update Posted Date

May 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective is the evaluation of the prognostic value of ctDNA (circulating tumor DNA) as a marker of surgical futility in patients with operable PDAC.

Detailed Description

In the era of personalized medicine and treatments guided by tumor biology, no specific tumor marker has real prognostic value. This is the reason why the search for a specific marker through a noninvasive blood test that can give indications on the usefulness of the resectability of pancreatic adenocarcinoma would be very valuable. Our project proposes the evaluation of ctDNA during various treatment courses of patients with PDAC in order to evaluate its efficacy as a prognostic and predictive marker of response to treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

165Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PDAC patients	Other	PDAC patients as described in the inclusion criteria	Other: ctDNA analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ctDNA analysis	Other	ctDNA amount and mutations analysis	PDAC patients

Measure	Description	Time Frame
Disease relapse	disease relapse at 2 years after surgery	2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with PDAC with indication to surgical resection, including those undergoing upfront surgery or surgery following induction treatment. Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded
Non-metastatic status confirmed by an abdomen CT-scan (as our routine clinical practice).
Patients able to give a specific informed consent.
Age ≥ 18 years.

Exclusion Criteria:

Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded (drop-out)
Non-controlled congestive heart failure.
Non-treated angina.
Recent myocardial infarction (in the previous year).
Non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment).
Long QT.
Major non-controlled infection.
Severe liver failure.
Age < 18 years.
Informed consent not signed.
Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
antonio pea, MD PHD	Contact	0458124671		antonio.pea@univr.it

Facility	Status	City	State	ZIP	Country	Contacts
AOUI Verona	Recruiting	Verona		37134	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided