Solid TumorsPROFILINGNCT03347318
Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease
An observational study of Solid Tumors, run by Fondazione del Piemonte per l'Oncologia at 15 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- How many people
- 2,500 participants
- Where
- 15 sitesItaly
- Study dates
- 30 Mar 2011to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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).
Who may be able to join
- 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
Show all 13Show fewer
- Breast Cancer
- Hepatocarcinoma
- Biliary Tract Carcinoma
- Lung Cancer (primary)
- Rare Tumors (incidence ≤ 5x10-6)
- Metastatic Sarcoma
- Metastatic Melanoma
Who cannot join
- -
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites
Ospedale Regionale Umberto Parini
Aosta
Policlinico S.Orsola Malpighi
Bologna
Istituto Di Candiolo - Fondazione Del Piemonte Per L'Oncologia (FPO-Irccs)
Candiolo
Azienda Ospedaliero-Universitaria Careggi
Genova
Azienda Ospedaliera Niguarda Ca'Granda
Milan
IEO - Istiuto Europeo di Oncologia
Milan
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan
AOU S. Luigi Gonzaga
Orbassano
IOV - Istituto Oncologico Veneto
Padova
Azienda Ospedaliero Universitaria Pisana
Pisa
Policlinico Universitario Campus Biomedico
Roma
A.O. Città della Salute e della Scienza di Torino - Presidio ospedaliero Ostetrico Ginecologico Sant'Anna
Turin
AOU Città della Salute e della Scienza di Torino - Presidio Molinette
Turin
Ospedale Mauriziano Umberto I
Turin
Presidio Ospedaliero Martini
Turin
About this study
Official title: Non-interventional Study for the Determination of Molecular Resistance Profiling to Targeted Therapies in Patients With Neoplastic Disease
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.
- Conditions
- Solid Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient correctly sampled
number of patients with biological samples idoneous for molecular profiling testing (nucleic acid extraction, protein) over all recruited patients.
Measured: 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.
Measured: through study completion, an average of five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start30 Mar 2011
- Primary completion15 Mar 2026
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347318
- Sponsor's protocol ID
- 001-IRCC-00IIS-10
- Acronym
- PROFILING
- Status last verified
- Mar 2026
- First submitted
- 18 Jul 2017
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study for the Determination of Molecular Resistance Profiling to Targeted Therapies in Patients With Neoplastic Disease
- ClinicalTrials.gov ID
- NCT03347318
- Acronym / sponsor ID
- PROFILING / 001-IRCC-00IIS-10
- Conditions
- Solid Tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 30 Mar 2011 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (13 listed)
- Colorectal Cancer (primary or with synchronous/metachronous liver metastases)
- Prostate Cancer
- Head \& Neck Tumors
- Gastric Cancer
- Glioblastoma
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of patient correctly sampled
Time frame: through study completion, an average of five years
number of patients with biological samples idoneous for molecular profiling testing (nucleic acid extraction, protein) over all recruited patients.
1 secondary outcome
number of patients with detected genetic alterations that respond to treatments assigned by physician.
Time frame: through study completion, an average of five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumors, run by Fondazione del Piemonte per l'Oncologia at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patient correctly sampled (time frame: through study completion, an average of five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.