NCT03347318

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
active not recruiting

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

March 30, 2011

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

15 years

First QC Date

July 18, 2017

Last Update Submit

March 17, 2026

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • number of patients with detected genetic alterations that respond to treatments assigned by physician.

    through study completion, an average of five years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Ospedale Regionale Umberto Parini

Aosta, Italy

Location

Policlinico S.Orsola Malpighi

Bologna, Italy

Location

Istituto Di Candiolo - Fondazione Del Piemonte Per L'Oncologia (FPO-Irccs)

Candiolo, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Genova, Italy

Location

Azienda Ospedaliera Niguarda Ca'Granda

Milan, Italy

Location

IEO - Istiuto Europeo di Oncologia

Milan, Italy

Location

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Italy

Location

AOU S. Luigi Gonzaga

Orbassano, Italy

Location

IOV - Istituto Oncologico Veneto

Padua, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, Italy

Location

A.O. Città della Salute e della Scienza di Torino - Presidio ospedaliero Ostetrico Ginecologico Sant'Anna

Turin, Italy

Location

AOU Città della Salute e della Scienza di Torino - Presidio Molinette

Turin, Italy

Location

Ospedale Mauriziano Umberto I

Turin, Italy

Location

Presidio Ospedaliero Martini

Turin, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, feces, urine and tumor specimens

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

November 20, 2017

Study Start

March 30, 2011

Primary Completion

March 15, 2026

Study Completion

March 31, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

IT(15)