Metastatic Colorectal CancerFUNNELNCT03350412
Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
An observational study of Metastatic Colorectal Cancer, run by Fondazione del Piemonte per l'Oncologia at 5 sites in Italy.
Trial summary
The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 1,000 participants
- Where
- 5 sitesItaly
- Study dates
- Oct 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: FUNNEL population consists of individual at least 18 years of age with newly diagnosed metastatic colorectal carcinoma at the first sign of metastasis (adjuvant relapse or first diagnosis)
Who may be able to join
- Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.
- Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital.
- Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year.
- Age ≥18.
- ECOG PS 0-1.
- No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
- Signed informed consent.
Who cannot join
- Symptomatic brain metastases.
- Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption.
- History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years.
- No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
Trial locations and contacts
5 sites in 1 country.
Massimo Aglietta, md contact
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
AOU Policlinico S Orsola - Malpighi
Bologna
Andrea Ardizzoni, MD, andrea.ardizzoni@aosp.bo.it
- Recruiting
Policlinico S.Orsola Malpighi
Bologna
Andrea Ardizzoni, MD, andrea.ardizzoni@aosp.bo.it
- Recruiting
Fondazione del Piemonte per l'Oncologia
Candiolo, 10060
Francesco Leone, MD, francesco.leone@ircc.it
- Recruiting
IOV - Istituto Oncologico Veneto
Padova
Vittorina Zagonel, MD, vittorina.zagonel@iov.veneto.it
- Recruiting
Policlinico Universitario Campus Biomedico
Roma
Giuseppe Tonini, MD, g.tonini@unicampus.it
About this study
Official title: Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.
- Conditions
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoroughness to report molecular profiling
Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition.
Measured: 14 days from sample acquisition
Secondary outcomes (2)
Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC
number of patients with detected genetic alteration included in the panel (mutations and/or copy number variations) over all recruited patients.
Measured: 24 months from first patient in.
Percentage of complete data capture for treatment-related check-point events
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 posted22 Nov 2017
- Study startOct 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Aglietta, md, Principal investigator, Fondazione del Piemonte per l'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350412
- Sponsor's protocol ID
- 007-IRCC-10IIS-14
- Acronym
- FUNNEL
- Status last verified
- Oct 2018
- First submitted
- 18 Jul 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials
- ClinicalTrials.gov ID
- NCT03350412
- Acronym / sponsor ID
- FUNNEL / 007-IRCC-10IIS-14
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 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 goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.
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
- FUNNEL population consists of individual at least 18 years of age with newly diagnosed metastatic colorectal carcinoma at the first sign of metastasis (adjuvant relapse or first diagnosis)
Key inclusion criteria (7 listed)
- Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.
- Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital.
- Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year.
- Age ≥18.
- ECOG PS 0-1.
Key exclusion criteria (4 listed)
- Symptomatic brain metastases.
- Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption.
- History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years.
- No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
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
Thoroughness to report molecular profiling
Time frame: 14 days from sample acquisition
Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition.
2 secondary outcomes
Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC
Time frame: 24 months from first patient in.
Percentage of complete data capture for treatment-related check-point events
Time frame: through study completion, an average of five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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CRC
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.
Massimo Aglietta, md contact
Massimo Aglietta, md principal investigator
Fondazione del Piemonte per l'Oncologia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Fondazione del Piemonte per l'Oncologia at 5 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Aglietta, md (massimo.aglietta@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoroughness to report molecular profiling (time frame: 14 days from sample acquisition). 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 30 Oct 2018.