Solid TumorPOPCORNNCT06028724
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
An observational study of Solid Tumor and Advanced Solid Tumor, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Solid Tumor, Locally Advanced Solid Tumor
- How many people
- 782 participants
- Where
- 1 siteItaly
- Study dates
- 26 May 2023to 31 May 2030
- 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 who are receiving therapy for advanced and locally advanced solid tumor as specified in eligibility criteria
Who may be able to join
- Patients eligible for inclusion in this study have to meet all of the following criteria:
- Patients, 18 years of age or older
- Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Histologically proven diagnosis solid tumor
- Diagnosis of advanced or locally advanced disease
Show all 18Show fewer
- Patients candidated to receive standard therapy in the following line:
- first, second or third-line therapy for colon-rectal cancer in IV stage
- first or second-line therapy for gastric cancer in IV stage
- primary intent or first-line therapy for pancreatic cancer
- first-line therapy for bile duct cancer
- first or second-line therapy for hepatocarcinoma
- first, second, third, fourth or fifth-line therapy for breast cancer in IV stage
- chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse
- first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)
- first or second-line therapy for advanced or locally advanced cervical cancer
- therapy for locally advanced or first line therapy for metastatic vulva cancer
- first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)
Who cannot join
- Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Cudia, MSc contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, 33081
Fabio Puglisi, MD, PhD
About this study
Official title: A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.
- Conditions
- Solid Tumor, Advanced Solid Tumor, Locally Advanced Solid Tumor, Colon Rectal Cancer, Gastric Cancer, Pancreatic Cancer
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Bile Duct Neoplasms, Carcinoma, Hepatocellular, Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Real world prevalence of clinically useful mutations in solid tumors
Real world prevalence of clinically useful mutations in solid tumors, defined as the proportion of patients with the detection of clinically useful mutations through ctDNA NGS, at the beginning of systemic therapies defined as per inclusion criteria for advanced disease.
Measured: at the beginning of treatment
Secondary outcomes (6)
To identify emerging gene alterations associated with Progression Free Survival
To identify emerging gene alterations associated with Progression Free Survival (PFS) defined as the time from study enrollment until progression or death for any cause, whichever comes first
Measured: from study enrollment until progression or death for any cause, up to 7 years
To identify emerging gene alterations associated with Overall Survival
To identify emerging gene alterations associated with Overall Survival, defined as the time from study enrollment until death for any cause
Measured: from study enrollment until death for any cause, up to 7 years
To describe changes in ctDNA associated biomarkers during treatment
Difference in frequency of patients with ctDNA associated biomarkers at different time point during treatment (at baseline, at start of cycle 2, at first radiological evaluation, at relapse or end of follow-up)
Measured: up to 7 years
To evaluate the association between somatic genetic alterations and the histopathological features of the tumor
Frequency of somatic genetic alterations in subgroups of patients with different histopathological tumor characteristics
Measured: up to 7 years
To evaluate the association between somatic genetic alterations and pattern of metastasis
Frequency of somatic genetic alterations in subgroups of patients with metastasis
Measured: up to 7 years
To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients
Frequency of somatic genetic alterations in subgroups of patients with different clinical characteristics
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start26 May 2023
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 782 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Puglisi, MD, PhD, Principal investigator, IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028724
- Sponsor's protocol ID
- CRO-2022-51
- Acronym
- POPCORN
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
- ClinicalTrials.gov ID
- NCT06028724
- Acronym / sponsor ID
- POPCORN / CRO-2022-51
- Conditions
- Solid Tumor, Advanced Solid Tumor, Locally Advanced Solid Tumor, Colon Rectal Cancer, Gastric Cancer, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 782 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 8 Sep 2023 (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 implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.
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 who are receiving therapy for advanced and locally advanced solid tumor as specified in eligibility criteria
Key inclusion criteria (18 listed)
- Patients, 18 years of age or older
- Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Histologically proven diagnosis solid tumor
- Diagnosis of advanced or locally advanced disease
Key exclusion criteria (2 listed)
- Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints
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
Real world prevalence of clinically useful mutations in solid tumors
Time frame: at the beginning of treatment
Real world prevalence of clinically useful mutations in solid tumors, defined as the proportion of patients with the detection of clinically useful mutations through ctDNA NGS, at the beginning of systemic therapies defined as per inclusion criteria for advanced disease.
6 secondary outcomes
To identify emerging gene alterations associated with Progression Free Survival
Time frame: from study enrollment until progression or death for any cause, up to 7 years
To identify emerging gene alterations associated with Overall Survival
Time frame: from study enrollment until death for any cause, up to 7 years
To describe changes in ctDNA associated biomarkers during treatment
Time frame: up to 7 years
To evaluate the association between somatic genetic alterations and the histopathological features of the tumor
Time frame: up to 7 years
To evaluate the association between somatic genetic alterations and pattern of metastasis
Time frame: up to 7 years
To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients
Time frame: up to 7 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 13 Sep 2023.
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A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
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Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR 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.
Giulia Cudia, MSc contact
Fabio Puglisi, MD, PhD principal investigator
IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
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 Solid Tumor and Advanced Solid Tumor, run by Centro di Riferimento Oncologico - Aviano at 1 site 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 18 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Sep 2023. 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 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?
Contact Fabio Puglisi, MD, PhD (0434659253, fabio.puglisi@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real world prevalence of clinically useful mutations in solid tumors (time frame: at the beginning of treatment). 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 13 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.