RAS Wild Type mCRCPERSEIDANCT02792478
Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type.PERSEIDA Study
An observational study of RAS Wild Type mCRC, run by Amgen at 24 sites in Spain.
Trial summary
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RAS Wild Type mCRC
- How many people
- 238 participants
- Where
- 24 sitesSpain
- Study dates
- 6 May 2016to 31 May 2021
- 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: Subjects with metastatic colorectal cancer, measurable by RECIST, who start first-line treatment
Who may be able to join
- Subjects who give their informed consent in writing
- Subjects with metastatic colorectal cancer, measurable by RECIST, who start first-line treatment
- Male and female subjects, at least 18 years of age and of any ethnicity
- Subjects with a histologically-confirmed diagnosis of colorectal carcinoma with metastatic disease and wild-type RAS.
Who cannot join
- Pregnant or breastfeeding women
- Subjects who have previously received monoclonal antibodies against EGFR (cetuximab or panitumumab), small-molecule EGFR inhibitors (such as erlotinib) or other biological cancer treatments
- History of another solid or haematological tumour in the previous 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer
- Subjects who are participating or have participated in a clinical trial in the 30 days prior to inclusion.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Spain24 sites
Research Site
Alicante, Valencia, 03010
Research Site
Almería, Andalusia, 04009
Research Site
Avilés, Principality of Asturias, 33400
Research Site
Burgos, Castille and León, 09006
Research Site
Cáceres, Extremadura, 10003
Research Site
Cartagena, Murcia, 30202
Research Site
Castellon, Valencia, 12002
Research Site
Granada, Andalusia, 18014
Research Site
Lleida, Catalonia, 25198
Research Site
Madrid, 28009
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Murcia, 30008
Research Site
Ourense, Galicia, 32005
Research Site
Oviedo, Principality of Asturias, 33011
Research Site
Palma de Mallorca, Balearic Islands, 07198
Research Site
Salamanca, Castille and León, 37007
Research Site
San Cristóbal de La Laguna, Canary Islands, 38320
Research Site
Seville, Andalusia, 41013
Research Site
Terrassa, Catalonia, 08221
Research Site
Valencia, Valencia, 46014
Research Site
Valencia, Valencia, 46015
Research Site
Valencia, Valencia, 46026
About this study
Official title: Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type Colorectal Cancer in First-line Treatment: a Prospective, Observational Multi-centre Study in Spain. PERSEIDA Study
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method
Read the detailed description
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method is proposed as a technique that may be useful for analysing the RAS mutation status in different types of cancer. However, first it is necessary to evaluate the concordance between the results obtained in tumour samples and liquid biopsies.
Primary objective
- To evaluate the RAS mutation status at baseline in liquid biopsies in subjects with RAS wild-type metastatic colorectal cancer.
Secondary objectives
- To evaluate the appearance of new RAS mutations using liquid biopsies at the moment of disease progression.
- To evaluate the appearance of new RAS mutations using liquid biopsies prior to radiological documentation of disease progression.
- Conditions
- RAS Wild Type mCRC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RAS wild-type subjects | The blood samples will be collected according to the site's routine clinical practice usually prior to each treatment cycle and at the follow-up visits. Analysis of the RAS mutation status will be carried out on blood samples taken at baseline, on those carried out at 20 +/-2 weeks after the start of treatment (in any case, prior to the second tumour assessment) and on the sample obtained upon progression, coinciding with routine clinical practices for collecting blood. Blood Samples will be collected to all subjects participating (119 subjects.)Objective to evaluate the RAS mutation status at baseline in liquid biopsies in subjects with RAS wild type metastatic colorectal cancer. | |
| Patient RAS WT | As in cohort 1 blood samples will be collected for all subjects participating (119) 10 ml will be used for analysis of the RAS mutation status. The mutation status of BRAF and EGFR will be also analysed with the IdyllaTM (Biocartis) tests in this Cohort 2. In 20 patients included in Cohort 2, 10 ml additional taken at baseline will be used in order to determine the RAS mutation status by the BEAMing technique and 10 ml additional taken at disease progression will be used to determine the mutational profile in genes other than RAS by a NGS technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.
To evaluate the RAS mutation status at baseline in liquid biopsies in two cohorts of subjects with RAS wild-type metastatic colorectal cancer: one analysed with the BEAMing (Sysmex-Inostics) technique (Cohort 1) and the other one analysed with the IdyllaTM (Biocartis) tests (Cohort 2).
Measured: Baseline
Secondary outcomes (2)
Description of RAS mutations using liquid biopsies at the moment of disease progression
Serial protocol specified radiographic and clinical assessment until disease progression
One (plasma DNA) liquid biopsy performed at the time progression is documented.
Progression time cannot be determined in advance of it's occurrence.
Measured: Median time to progression ranges from 12 to 24 months
Description of the RAS mutations using liquid biopsies at 20 +/-2 weeks after starting treatment and prior to the second radiological assessment of the disease.
The percentage of subjects who present RAS mutations in liquid biopsies taken prior to the second disease assessment will be presented.
Measured: at 20+/- 2 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start6 May 2016
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RAS Wild Type mCRCStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792478
- Sponsor's protocol ID
- 20140381
- Acronym
- PERSEIDA
- Status last verified
- May 2024
- First submitted
- 26 Apr 2016
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Valladares-Ayerbes M, Safont MJ, Gonzalez Flores E, Garcia-Alfonso P, Aranda E, Munoz AL, Falco Ferrer E, Cirera Nogueras L, Rodriguez-Salas N, Aparicio J, Llanos Munoz M, Pimentel Caceres PP, Castillo Trujillo OA, Vidal Tocino R, Salgado Fernandez M, Salud-Salvia A, Massuti Sureda B, Garcia-Carbonero R, Vicente Conesa MA, Lloansi Vila A; PERSEIDA investigators. Sequential RAS mutations evaluation in cell-free DNA of patients with tissue RAS wild-type metastatic colorectal cancer: the PERSEIDA (Cohort 2) study. Clin Transl Oncol. 2024 Oct;26(10):2640-2651. doi: 10.1007/s12094-024-03487-4. Epub 2024 Apr 20.
PubMed 38642257
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of RAS Mutation Status in Liquid Biopsies in Subjects With RAS Wild-type Colorectal Cancer in First-line Treatment: a Prospective, Observational Multi-centre Study in Spain. PERSEIDA Study
- ClinicalTrials.gov ID
- NCT02792478
- Acronym / sponsor ID
- PERSEIDA / 20140381
- Conditions
- RAS Wild Type mCRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 May 2016 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 7 Jun 2016 (estimated)
- 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.
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method
Detailed description
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method is proposed as a technique that may be useful for analysing the RAS mutation status in different types of cancer. However, first it is necessary to evaluate the concordance between the results obtained in tumour samples and liquid biopsies.
Primary objective
- To evaluate the RAS mutation status at baseline in liquid biopsies in subjects with RAS wild-type metastatic colorectal cancer.
Secondary objectives
- To evaluate the appearance of new RAS mutations using liquid biopsies at the moment of disease progression.
- To evaluate the appearance of new RAS mutations using liquid biopsies prior to radiological documentation of disease progression.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAS wild-type subjects | – | –The blood samples will be collected according to the site's routine clinical practice usually prior to each treatment cycle and at the follow-up visits. Analysis of the RAS mutation status will be carried out on blood samples taken at baseline, on those carried out at 20 +/-2 weeks after the start of treatment (in any case, prior to the second tumour assessment) and on the sample obtained upon progression, coinciding with routine clinical practices for collecting blood. Blood Samples will be collected to all subjects participating (119 subjects.)Objective to evaluate the RAS mutation status at baseline in liquid biopsies in subjects with RAS wild type metastatic colorectal cancer. |
| Patient RAS WT | – | –As in cohort 1 blood samples will be collected for all subjects participating (119) 10 ml will be used for analysis of the RAS mutation status. The mutation status of BRAF and EGFR will be also analysed with the IdyllaTM (Biocartis) tests in this Cohort 2. In 20 patients included in Cohort 2, 10 ml additional taken at baseline will be used in order to determine the RAS mutation status by the BEAMing technique and 10 ml additional taken at disease progression will be used to determine the mutational profile in genes other than RAS by a NGS technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with metastatic colorectal cancer, measurable by RECIST, who start first-line treatment
Key inclusion criteria (4 listed)
- Subjects who give their informed consent in writing
- Subjects with metastatic colorectal cancer, measurable by RECIST, who start first-line treatment
- Male and female subjects, at least 18 years of age and of any ethnicity
- Subjects with a histologically-confirmed diagnosis of colorectal carcinoma with metastatic disease and wild-type RAS.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Subjects who have previously received monoclonal antibodies against EGFR (cetuximab or panitumumab), small-molecule EGFR inhibitors (such as erlotinib) or other biological cancer treatments
- History of another solid or haematological tumour in the previous 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer
- Subjects who are participating or have participated in a clinical trial in the 30 days prior to inclusion.
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
Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline.
Time frame: Baseline
To evaluate the RAS mutation status at baseline in liquid biopsies in two cohorts of subjects with RAS wild-type metastatic colorectal cancer: one analysed with the BEAMing (Sysmex-Inostics) technique (Cohort 1) and the other one analysed with the IdyllaTM (Biocartis) tests (Cohort 2).
2 secondary outcomes
Description of RAS mutations using liquid biopsies at the moment of disease progression
Time frame: Median time to progression ranges from 12 to 24 months
Description of the RAS mutations using liquid biopsies at 20 +/-2 weeks after starting treatment and prior to the second radiological assessment of the disease.
Time frame: at 20+/- 2 weeks after treatment start
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 13 May 2024.
- Background: PubMed 38642257Valladares-Ayerbes M, Safont MJ, Gonzalez Flores E, Garcia-Alfonso P, Aranda E, Munoz AL, Falco Ferrer E, Cirera Nogueras L, Rodriguez-Salas N, Aparicio J, Llanos Munoz M, Pimentel Caceres PP, Castillo Trujillo OA, Vidal Tocino R, Salgado Fernandez M, Salud-Salvia A, Massuti Sureda B, Garcia-Carbonero R, Vicente Conesa MA, Lloansi Vila A; PERSEIDA investigators. Sequential RAS mutations evaluation in cell-free DNA of patients with tissue RAS wild-type metastatic colorectal cancer: the PERSEIDA (Cohort 2) study. Clin Transl Oncol. 2024 Oct;26(10):2640-2651. doi: 10.1007/s12094-024-03487-4. Epub 2024 Apr 20.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RAS Wild Type mCRC, run by Amgen at 24 sites in Spain.
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 4 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: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain. 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?
Detection rate of RAS mutations in liquid biopsies in subjects with RAS wild-type mCRC at baseline. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02792478, which also lists 1 linked publication.
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 13 May 2024.