Mestastatic ColoRectal CancerNCT04338542
A Retrospective Study Project of Clinico-molecular Characterization in Patients With Metastatic Colorectal Cancer
An observational study of Mestastatic ColoRectal Cancer, run by Sara De Dosso at 1 site in Switzerland.
Trial summary
This is a retrospective, translational, proof-of-concept study on tumor biopsies done on patients affected by mCRC and exhibiting RAS mutation. For each patient it will be selected the tissue biopsies of primary tumour and of paired resected metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mestastatic ColoRectal Cancer
- What is being tested?
- Tumor biobsies analysis
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Apr 2020to 2 Jul 2020
- 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
- Adult, Older adult
Study population: metastatic ColoRectal Cancer patients exhibiting RAS mutation and who received a treatment
General inclusion criteria (valid for all the three cohorts):
- patients with biopsy-proven, stage IV CRC;
- RAS mutation at diagnosis;
- availability of tissue biopsy/resection of both primary tumour and paired liver metastasis for the molecular characterization;
General exclusion criteria (valid for all the three cohorts):
- inadequate material for the molecular characterization of the primary tumour and/or of the related metastasis;
- insufficient amount (%) of tumour cells;
Specific inclusion criteria for each group:
- st group:
- first-line bevacizumab plus chemotherapy before resection of liver metastases;
- metastases must be resected metachronously with respect to the primary tumor.
- nd group:
- first-line chemotherapy without bevacizumab before resection of liver metastases;
- metastases must be resected metachronously with respect to the primary tumor.
- rd group:
- no systemic therapy (immediate surgical resection of primary tumor and paired liver metastases);
- primary tumour and metastasis can be synchronous or metachronous.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
About this study
Official title: A Proof-of-concept Study Investigating the Comparison of the RAS Mutational Status Between Primary Tumor and Metastasis in Patients Affected by Metastatic Colorectal Cancer on the Basis of Different Chemotherapeutic Regimens
This is a retrospective, translational, proof-of-concept study on tumor biopsies done on patients affected by mCRC and exhibiting RAS mutation.
For each patient it will be selected the tissue biopsies of primary tumour and of paired resected metastasis.
Read the detailed description
the study implies the subdivision into three groups with a 1:1:1 ratio.
- The first group includes patients treated with surgery of the primary tumor, neoadjuvant chemotherapy plus bevacizumab and, finally, the surgical resection of liver metastasis.
- The second group is similar to group one, with the exception that patients were not treated with a bevacizumab-based regimen.
- The third group, the control group, includes patients presenting with synchronous primary tumour and metastasis resected without any preoperative systemic therapy
Genomic DNA from formalin-fixed paraffin-embedded (FFPE) tissues from the primary tumor and metastatic lesions will be extracted. The genomic DNA will be assessed for the RAS mutational status in a quantitative and qualitative manner using two different approaches: a real-time PCR approach using the SensiScreen® kit (PentaBase Aps) and a next-generation sequencing approach using the Ion Torrent platform by applying the Ion AmpliSeq™ Cancer Hotspot Panel v2 (ThermoFisher Scientific). The real-time PCR is able to provide the relative quantification of the RAS mutant allele by comparing the Ct value of the mutation with respect to the Ct of the reference gene. This ratio will be calculated for both the primary tumor and for the metastasis and then compared. Ion Torrent gives directly the percentage of the mutant allele in each sample. Furthermore, the Cancer Hotspot Panel v2 provides data (both quantitative and qualitative) about the mutational status of additional 49 genes, including the most relevant and frequently mutated genes in CRC (i.e.: APC, TP53, PIK3CA, BRAF and PTEN) and the relative mutational pattern of the primary tumor and the one of the distant metastasis will be compared.
- Conditions
- Mestastatic ColoRectal Cancer
- Being tested
- Tumor biobsies analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biobsies analysisGenetic
Analysis on archived tumor biopsies
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemotherapy plus bevacizumab | Patients treated with surgery of the primary tumor, neoadjuvant chemotherapy plus bevacizumab and, finally, the surgical resection of liver metastasis. Receives: Genetic: Tumor biobsies analysis | |
| neoadjuvant chemotherapy | Patients treated with surgery of the primary tumor, neoadjuvant chemotherapy and, finally, the surgical resection of liver metastasis. Receives: Genetic: Tumor biobsies analysis | |
| control group | Patients presenting with synchronous primary tumour and metastasis resected without any preoperative systemic therapy. Receives: Genetic: Tumor biobsies analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of RAS mutant clones in the metastatic lesion
To confirm that the administration of an antiangiogenic treatment in mCRC RAS mutant patients before liver metastasis resection leads to a significant reduction of RAS mutant clones in the metastatic lesion
Measured: 6 months
Secondary outcomes (1)
Molecular patterns other than RAS
Compare molecular patterns other than RAS in the primary tumor and paired liver metastasis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start8 Apr 2020
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mestastatic 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
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara De Dosso
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Cantonale di Patologia, Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Sara De Dosso, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Sara De Dosso, MD, Study chair, Ente Ospedaliero Cantonale, BellinzonaMilo Frattini, MD, Principal investigator, Istituto Cantonale Patologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338542
- Sponsor's protocol ID
- IOSI-ICP-001
- Status last verified
- Aug 2020
- First submitted
- 5 Apr 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study Investigating the Comparison of the RAS Mutational Status Between Primary Tumor and Metastasis in Patients Affected by Metastatic Colorectal Cancer on the Basis of Different Chemotherapeutic Regimens
- ClinicalTrials.gov ID
- NCT04338542
- Acronym / sponsor ID
- IOSI-ICP-001
- Conditions
- Mestastatic ColoRectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sara De DossoUniversity, hospital or other
- Collaborators
- Istituto Cantonale di Patologia, Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 8 Apr 2020 (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.
This is a retrospective, translational, proof-of-concept study on tumor biopsies done on patients affected by mCRC and exhibiting RAS mutation.
For each patient it will be selected the tissue biopsies of primary tumour and of paired resected metastasis.
Detailed description
the study implies the subdivision into three groups with a 1:1:1 ratio.
- The first group includes patients treated with surgery of the primary tumor, neoadjuvant chemotherapy plus bevacizumab and, finally, the surgical resection of liver metastasis.
- The second group is similar to group one, with the exception that patients were not treated with a bevacizumab-based regimen.
- The third group, the control group, includes patients presenting with synchronous primary tumour and metastasis resected without any preoperative systemic therapy
Genomic DNA from formalin-fixed paraffin-embedded (FFPE) tissues from the primary tumor and metastatic lesions will be extracted. The genomic DNA will be assessed for the RAS mutational status in a quantitative and qualitative manner using two different approaches: a real-time PCR approach using the SensiScreen® kit (PentaBase Aps) and a next-generation sequencing approach using the Ion Torrent platform by applying the Ion AmpliSeq™ Cancer Hotspot Panel v2 (ThermoFisher Scientific). The real-time PCR is able to provide the relative quantification of the RAS mutant allele by comparing the Ct value of the mutation with respect to the Ct of the reference gene. This ratio will be calculated for both the primary tumor and for the metastasis and then compared. Ion Torrent gives directly the percentage of the mutant allele in each sample. Furthermore, the Cancer Hotspot Panel v2 provides data (both quantitative and qualitative) about the mutational status of additional 49 genes, including the most relevant and frequently mutated genes in CRC (i.e.: APC, TP53, PIK3CA, BRAF and PTEN) and the relative mutational pattern of the primary tumor and the one of the distant metastasis will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy plus bevacizumab | – | Genetic: Tumor biobsies analysisPatients treated with surgery of the primary tumor, neoadjuvant chemotherapy plus bevacizumab and, finally, the surgical resection of liver metastasis. |
| neoadjuvant chemotherapy | – | Genetic: Tumor biobsies analysisPatients treated with surgery of the primary tumor, neoadjuvant chemotherapy and, finally, the surgical resection of liver metastasis. |
| control group | – | Genetic: Tumor biobsies analysisPatients presenting with synchronous primary tumour and metastasis resected without any preoperative systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- metastatic ColoRectal Cancer patients exhibiting RAS mutation and who received a treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor biobsies analysisAnalysis on archived tumor biopsies | Genetic | control group, neoadjuvant chemotherapy, neoadjuvant chemotherapy plus bevacizumab |
Primary outcome
Change of RAS mutant clones in the metastatic lesion
Time frame: 6 months
To confirm that the administration of an antiangiogenic treatment in mCRC RAS mutant patients before liver metastasis resection leads to a significant reduction of RAS mutant clones in the metastatic lesion
1 secondary outcome
Molecular patterns other than RAS
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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.
Sara De Dosso, MD study chair
Ente Ospedaliero Cantonale, Bellinzona
Milo Frattini, MD principal investigator
Istituto Cantonale Patologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mestastatic ColoRectal Cancer, run by Sara De Dosso at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of RAS mutant clones in the metastatic lesion (time frame: 6 months). 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 11 Aug 2020.