ClinicalTrials.gg
RecruitingNCT04510766Updated Nov 18, 2025

Tumor Molecular Profiling in Early Phase Clinical Trials

An observational study in Advanced Solid Tumor and Lymphoma, sponsored by Oncology Institute of Southern Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Oncology Institute of Southern Switzerland · Observational

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 71 studies in Lymphoma with a site in Switzerland — 6 open to participants now, 11 under way, 5 of them phase 3. Lymphoma · Switzerland.

Started
2020
with 1 other
Observational
5 of 71
3 open now
Primary completion
2026-12
later than 4 of 10 live
Registered
61st of 71
by date

Among the 71 studies in Lymphoma with a site in Switzerland, this one is one of 2 that started in 2020, is one of 5 observational ones, reaches primary completion later than 4 of the 10 other live ones, and was the 61st registered.

Lymphoma

3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.

Browse Lymphoma studies →

Open to participants now

6 of the 71 studies in Lymphoma with a site in Switzerland are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 347 Lymphoma studies recruiting now, 227 (65%) set no upper age limit and 79 (23%) stop at 75 or younger; 78 take children under 18; 20 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 71 studies in Lymphoma with a site in Switzerland, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Advanced Solid Tumor
  • Lymphoma

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients age at least 18 years.
  2. Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
  3. (ECOG) Performance Status 0 or 1
  4. Live expectancy of at least 6 months.
  5. Availability of FFPE from previous surgery or diagnostic biopsy adequate for molecular analysis.
  6. Ability to understand the patient information and study consent. Signed and dated written must be available before performing any study-related procedure.
  7. Willing and able to comply with study procedures

Exclusion criteria

Exclusion Criteria:

  1. Presence of any clinical (e.g. concomitant disease, symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial.
  2. Any other active (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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Accrual rate in early phase clinical trials

    Number of patients with available molecular profile enrolled per year

    Time frame: Two years

Secondary outcomes

  1. Clinical Outcome

    Response rate among patients with available molecular tumor profiling that have been enrolled in an early phase clinical trial

    Time frame: Two years

  2. Number of successful NGS-based DNA analysis performed on archival tissue

    Type and frequency of mutations identified on archival tissue

    Time frame: Two years

  3. Number of NGS-based RNA-seq samples analyzed

    Analysis performed on archival tissue

    Time frame: Two years

  4. Rate of stored samples

    Number of blood samples collected and stored for ctDNA analysis

    Time frame: Two years

07

Study locations

1 of 1 sites recruiting
  • Oncology Institute of Southern Switzerland
    Bellinzona, 6500, Switzerland
    Recruiting
    • Ilaria Colombo, MD · Contactilaria.colombo@eoc.ch · +41 (0)91 811 8194
    • Anastasios Stathis, PD MD · Principal investigator
    • Milo Frattini, PhD · Principal investigator
    • Francesco Bertoni, Prof. MD · Principal investigator
    • Davide Rossi, Prof. MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2020 (actual). Primary completion is estimated for Dec 2026, 74 months after the start.

Of 140 non-industry observational studies under Lymphoma, half reached primary completion within 90 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 269. This study's planned 74 months is below that.

Counting every sponsor, half of 159 studies reached it within 82 months; a quarter within 39 and three quarters within 269.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2020
First posted
Aug 12, 2020
StartActual
Oct 1, 2020
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Nov 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04510766
Lead sponsor
Oncology Institute of Southern Switzerland
Collaborators
Ente Ospedaliero Cantonale, Bellinzona, Istituto Cantonale di Patologia
Responsible party
Sponsor
First posted
Aug 12, 2020
Start date
Oct 1, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 18, 2025

Study contacts

Ilaria Colombo, MD
Contact
ilaria.colombo@eoc.ch
+41 (0)91 811 8194
Ilaria Colombo, MD
principal investigator · Oncology Institute of Southern Switzerlan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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