Advanced Solid TumorNCT04510766
Tumor Molecular Profiling in Early Phase Clinical Trials
An observational study of Advanced Solid Tumor and Lymphoma, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
Trial summary
Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Lymphoma
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2020to 31 Dec 2026
- 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 with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials
Who may be able to join
- Male or female patients age at least 18 years.
- Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Live expectancy of at least 6 months.
- Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis.
- Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure.
- Willing and able to comply with study procedures
Who cannot join
- Presence of any clinical (e.g. concomitant disease, clinically significant symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial.
- Any other active malignancy (other than the one for which the subject is being assessed for trial option) that is progressing or requiring active treatment with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Oncology Institute of Southern Switzerland
Bellinzona, 6500
Ilaria Colombo, MD, +41 (0)91 811 8194, ilaria.colombo@eoc.ch
Anastasios Stathis, PD MD
About this study
Official title: Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials
Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.
Read the detailed description
Single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials.
Part A: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 platform.
Part B: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with HTG EdgeSeq Oncology Biomarker Panel Assay for RNA-Seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctDNA at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.
- Conditions
- Advanced Solid Tumor, Lymphoma
- Medical subject headings
- Lymphoma
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 |
|---|---|---|
| Part A | Upon confirmation of the suitability for NGS analysis of the selected tumor sample, tumor DNA will be extracted and molecular profile will be performed using the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 according to manufacturer's instructions | |
| Part B | FFPE tumor archival tissue will be used to perform RNA-Seq with NGS HTG EdgeSeq Oncology Biomarker Panel Assay using the HTG machine following the manufacture's protocol. Blood samples for "liquid biopsy" will be collected at two time points: 1) Any time after enrollment in an early clinical trial and before starting the investigational agent (1 x 10 ml blood sample in EDTA tube as source of normal DNA for comparative analysis; 2 x 10 ml blood samples in cell-free DNA BCT Tubes for ctDNA collection; 2) At the time of radiological or clinical tumor progression (2 x 10 ml blood samples in cell-free DNA BCT Tubes for ctDNA collection). Blood samples will be collected and stored to create a biobank of "liquid biopsy" for future analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate in early phase clinical trials
Number of patients with available molecular profile enrolled per year
Measured: Two years
Secondary outcomes (4)
Clinical Outcome
Response rate among patients with available molecular tumor profiling that have been enrolled in an early phase clinical trial
Measured: Two years
Number of successful NGS-based DNA analysis performed on archival tissue
Type and frequency of mutations identified on archival tissue
Measured: Two years
Number of NGS-based RNA-seq samples analyzed
Analysis performed on archival tissue
Measured: Two years
Rate of stored samples
Number of blood samples collected and stored for ctDNA analysis
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Ente Ospedaliero Cantonale, Bellinzona, Istituto Cantonale di Patologia
- Responsible party
- Sponsor
- Investigators
- Ilaria Colombo, MD, Principal investigator, Oncology Institute of Southern Switzerlan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510766
- Sponsor's protocol ID
- IOSI-USNF-001
- Status last verified
- Nov 2025
- First submitted
- 10 Aug 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials
- ClinicalTrials.gov ID
- NCT04510766
- Acronym / sponsor ID
- IOSI-USNF-001
- Conditions
- Advanced Solid Tumor, Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- Ente Ospedaliero Cantonale, Bellinzona, Istituto Cantonale di Patologia
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Aug 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.
Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.
Detailed description
Single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials.
Part A: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 platform.
Part B: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with HTG EdgeSeq Oncology Biomarker Panel Assay for RNA-Seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctDNA at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | – | –Upon confirmation of the suitability for NGS analysis of the selected tumor sample, tumor DNA will be extracted and molecular profile will be performed using the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 according to manufacturer's instructions |
| Part B | – | –FFPE tumor archival tissue will be used to perform RNA-Seq with NGS HTG EdgeSeq Oncology Biomarker Panel Assay using the HTG machine following the manufacture's protocol. Blood samples for "liquid biopsy" will be collected at two time points: 1) Any time after enrollment in an early clinical trial and before starting the investigational agent (1 x 10 ml blood sample in EDTA tube as source of normal DNA for comparative analysis; 2 x 10 ml blood samples in cell-free DNA BCT Tubes for ctDNA collection; 2) At the time of radiological or clinical tumor progression (2 x 10 ml blood samples in cell-free DNA BCT Tubes for ctDNA collection). Blood samples will be collected and stored to create a biobank of "liquid biopsy" for future analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials
Key inclusion criteria (7 listed)
- Male or female patients age at least 18 years.
- Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Live expectancy of at least 6 months.
- Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis.
Key exclusion criteria (2 listed)
- Presence of any clinical (e.g. concomitant disease, clinically significant symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial.
- Any other active malignancy (other than the one for which the subject is being assessed for trial option) that is progressing or requiring active treatment with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site.
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
Accrual rate in early phase clinical trials
Time frame: Two years
Number of patients with available molecular profile enrolled per year
4 secondary outcomes
Clinical Outcome
Time frame: Two years
Number of successful NGS-based DNA analysis performed on archival tissue
Time frame: Two years
Number of NGS-based RNA-seq samples analyzed
Time frame: Two years
Rate of stored samples
Time frame: Two 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 18 Nov 2025.
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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.
Ilaria Colombo, MD principal investigator
Oncology Institute of Southern Switzerlan
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 Advanced Solid Tumor and Lymphoma, run by Oncology Institute of Southern Switzerland 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?
The sponsor lists 7 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 18 Nov 2025. 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?
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 Ilaria Colombo, MD (+41 (0)91 811 8194, ilaria.colombo@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate in early phase clinical trials (time frame: Two years). 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 18 Nov 2025.