RAS Wild Type mCRC Clinical Trial
— PERSEIDAOfficial 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
| NCT number | NCT02792478 |
| Other study ID # | 20140381 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 6, 2016 |
| Est. completion date | May 31, 2021 |
| Verified date | May 2024 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Analysis of freely circulating DNA in liquid biopsies using the BEAMing method
| Status | Completed |
| Enrollment | 238 |
| Est. completion date | May 31, 2021 |
| Est. primary completion date | May 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion criteria: - 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. Exclusion criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | Alicante | Comunidad Valenciana |
| Spain | Research Site | Almeria | Andalucía |
| Spain | Research Site | Aviles | Asturias |
| Spain | Research Site | Burgos | Castilla León |
| Spain | Research Site | Caceres | Extremadura |
| Spain | Research Site | Cartagena | Murcia |
| Spain | Research Site | Castellon | Comunidad Valenciana |
| Spain | Research Site | Granada | Andalucía |
| Spain | Research Site | La Laguna | Canarias |
| Spain | Research Site | Lleida | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Murcia | |
| Spain | Research Site | Ourense | Galicia |
| Spain | Research Site | Oviedo | Asturias |
| Spain | Research Site | Palma de Mallorca | Baleares |
| Spain | Research Site | Salamanca | Castilla León |
| Spain | Research Site | Sevilla | Andalucía |
| Spain | Research Site | Terrassa | Cataluña |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Spain,
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 Apr 20. doi: 10.1007/s12094-024-03487-4. Online ahead of print. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Baseline | |
| Secondary | 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. |
Median time to progression ranges from 12 to 24 months | |
| Secondary | 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. | at 20+/- 2 weeks after treatment start |