Target Therapies Resistance Molecular Profiling in Patien... | NCT03347318

Studies
Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease

NCT03347318

Sponsor

Fondazione del Piemonte per l'Oncologia

Status

Active, not recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Solid Tumors

Interventions

Not provided

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2011Actual

Primary Completion Date

Mar 15, 2026Actual

Completion Date

Mar 31, 2026Estimated

First Submitted Date

Jul 18, 2017

First Submission Date that Met QC Criteria

Nov 17, 2017

First Posted Date

Nov 20, 2017Actual

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

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

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 purpose of this study is to define the molecular profile of selected solid tumors. From each participants will be collected biological materials for molecular analysis, including saliva, blood and vital tumor tissue derived form surgical or biopsy procedures. Whereas possible, vital tumor specimens will be inoculated and propagated in immunocompromised NOD/SCID mice to study the genetic correlations between genetic status and response to target drugs.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patient correctly sampled	number of patients with biological samples idoneous for molecular profiling testing (nucleic acid extraction, protein) over all recruited patients.	through study completion, an average of five years

Secondary Outcomes

Measure	Description	Time Frame
number of patients with detected genetic alterations that respond to treatments assigned by physician.		through study completion, an average of five years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with at least one of the following selected solid tumors:

Colorectal Cancer (primary or with synchronous/metachronous liver metastases)
Prostate Cancer
Head & Neck Tumors
Gastric Cancer
Glioblastoma
Breast Cancer
Hepatocarcinoma
Biliary Tract Carcinoma
Lung Cancer (primary)
Rare Tumors (incidence ≤ 5x10-6)
Metastatic Sarcoma
Metastatic Melanoma

Exclusion Criteria:

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

Patients with selected solid tumors (CRC, Prostate Cancer, Head & Neck Cancer, Gastric Cancer, Glioblastoma, Breast Cancer, Hepatocarcinoma, Biliary Tract Carcinoma, Lung Cancer, Rare Tumors, Metastatic Sarcoma and Metastatic Melanoma).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Regionale Umberto Parini		Aosta			Italy
Policlinico S.Orsola Malpighi