Neoplasm MalignantDSTNCT06782451
Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.
A study testing Surgery or biopsy and Blood sample in people with Neoplasm Malignant, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
This study aims to collect tumor samples from patients carrying a mutation of interest to develop a cell culture technique for "spheroids. The goal is to use these spheroids to model responses to anticancer treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- Surgery or biopsy and Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2025to 2 Jul 2030
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older.
- Patient for whom at least one mutation deemed of interest by the investigator has been identified.
- Patient with a malignant tumor at a locally advanced or metastatic stage, for whom a tissue tumor sample (via surgery, radiology, or endoscopy) is scheduled as part of their standard care.
- Tumor volume deemed sufficient by the physician to ensure an adequate amount of material for analysis by the pathologist and the transfer of a part of the tumor sample to the Laboratory of Translational Research in Oncology for the study.
- INR < 1.5; Platelets > 50,000/μL.
- Patient who has been informed of the study and has signed the informed consent form.
- Patient affiliated with a social security insurance.
Who cannot join
- Patient with multiple primary malignant tumors.
- Patient with a known HIV, Hepatitis C, or Hepatitis B infection.
- Patient on:
- Clopidogrel (hydrogensulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) with no possibility of suspension for 5 days,
- Low molecular weight heparin with no possibility of dose suspension before the procedure,
- Fondaparinux with no possibility of suspension,
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- Abciximab with no possibility of suspension for 24 hours and aPTT < 50s and ACT < 150s,
- Eptifibatide or Tirofiban Hydrochloride Monohydrate or Argatroban with no possibility of suspension 4 hours before the procedure,
- Bivalirudin with no possibility of suspension 2-3 hours if CrCL >50 mL/min or 3-5 hours if CrCL <50 mL/min before the procedure,
- Dabigatran etexilate with no possibility of suspension 2-3 days if CrCL >50 mL/min or 3-5 days if CrCL <50 mL/min before the procedure.
- Patient considered vulnerable; vulnerable persons are defined in articles L1121-5 to L1121-8:
- Pregnant women, parturients, and breastfeeding mothers,
- Individuals deprived of their liberty by a judicial or administrative decision, individuals hospitalized without consent under articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, and individuals admitted to a healthcare or social facility for reasons other than research,
- Adults under legal protection or unable to express their consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Study coordinator, DRCI-Promotion@nice.unicancer.fr
Esma SAADA-BOUZID
About this study
This study aims to collect tumor samples from patients carrying a mutation of interest to develop a cell culture technique for "spheroids.
The goal is to use these spheroids to model responses to anticancer treatments. Various therapeutic molecules can be tested on these spheroids, enabling the evaluation of the potential of new molecules or the activity of existing ones specifically on the tumor (bearing the mutation of interest) from which the spheroid was developed.
Tumor samples will be collected as part of biopsies or surgeries conducted during routine patient care.
- Conditions
- Neoplasm Malignant
- Being tested
- Surgery or biopsy, Blood sample
- Keywords
- Spheroids, Preclinic models
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery or biopsyProcedure or surgery
A part of the tumor sample collected during the surgery or the biopsy performed as part of routine patient care will be used for the research.
Blood sampleProcedure or surgery
38 mL of blood will be taken for the study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | For this study, the included patients will have a biopsy or a surgery performed as part of routine patient care. A part of the tumor sample will be transmitted to the Laboratory of Translational Research in Oncology to develop spheroids.
A blood sample will also be taken (38 mL) and analyzed by the Laboratory of Translational Research in Oncology in order to assess hematological toxicities of drugs and study a potential link between disease stage and the quantity of exosomes secreted. Receives: Procedure: Surgery or biopsy; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a cell culture technique for spheroids derived from fresh tumor samples collected among patients carrying a mutation of interest.
The primary evaluation criterion is the percentage of patients for whom viable spheroids were obtained from tumors with a molecular abnormality of interest, measured by cell viability one month after the tumor sample was collected.
Measured: 1 month
Secondary outcomes (3)
Obtain spheroids that are phenotypically and genotypically stable.
The phenotypic and genotypic stability of spheroids over time will be assessed using molecular characterization techniques (e.g., immunohistochemistry, sequencing).
Measured: 1 month
Validate preclinical models to study the tumor response to innovative therapies.
The ability of spheroids to mimic aspects of the tumor microenvironment, such as hypoxia and extracellular matrix formation, will be evaluated.
Measured: 1 month
Test the efficacy of molecules targeting variations identified in these tumors.
The response of the spheroids to specific anti-tumor therapies will be evaluated through drug sensitivity tests (e.g., cytotoxicity assays).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start2 May 2025
- Primary completion2 Jul 2030 (estimated)
- Study completion2 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782451
- Sponsor's protocol ID
- 2023/57
- Other IDs
- 2024-A01616-41
- Acronym
- DST
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Preclinical Models Derived From Tumors With a Molecular Abnormality of Interest to Test Their Sensitivity to New Anti-tumor Therapies.
- ClinicalTrials.gov ID
- NCT06782451
- Acronym / sponsor ID
- DST / 2023/57
- Conditions
- Neoplasm Malignant
- Keywords
- Spheroids, Preclinic models
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 2 Jul 2030 (estimated)
- Study completion
- 2 Jul 2030 (estimated)
- First posted
- 17 Jan 2025 (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.
This study aims to collect tumor samples from patients carrying a mutation of interest to develop a cell culture technique for "spheroids.
The goal is to use these spheroids to model responses to anticancer treatments. Various therapeutic molecules can be tested on these spheroids, enabling the evaluation of the potential of new molecules or the activity of existing ones specifically on the tumor (bearing the mutation of interest) from which the spheroid was developed.
Tumor samples will be collected as part of biopsies or surgeries conducted during routine patient care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Surgery or biopsy, Procedure: Blood sampleFor this study, the included patients will have a biopsy or a surgery performed as part of routine patient care. A part of the tumor sample will be transmitted to the Laboratory of Translational Research in Oncology to develop spheroids. A blood sample will also be taken (38 mL) and analyzed by the Laboratory of Translational Research in Oncology in order to assess hematological toxicities of drugs and study a potential link between disease stage and the quantity of exosomes secreted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Patient for whom at least one mutation deemed of interest by the investigator has been identified.
- Patient with a malignant tumor at a locally advanced or metastatic stage, for whom a tissue tumor sample (via surgery, radiology, or endoscopy) is scheduled as part of their standard care.
- Tumor volume deemed sufficient by the physician to ensure an adequate amount of material for analysis by the pathologist and the transfer of a part of the tumor sample to the Laboratory of Translational Research in Oncology for the study.
- INR < 1.5; Platelets > 50,000/μL.
Key exclusion criteria (14 listed)
- Patient with multiple primary malignant tumors.
- Patient with a known HIV, Hepatitis C, or Hepatitis B infection.
- Patient on:
- Patient considered vulnerable; vulnerable persons are defined in articles L1121-5 to L1121-8:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery or biopsyA part of the tumor sample collected during the surgery or the biopsy performed as part of routine patient care will be used for the research. | Procedure or surgery | Experimental |
| Blood sample38 mL of blood will be taken for the study. | Procedure or surgery | Experimental |
Primary outcome
Development of a cell culture technique for spheroids derived from fresh tumor samples collected among patients carrying a mutation of interest.
Time frame: 1 month
The primary evaluation criterion is the percentage of patients for whom viable spheroids were obtained from tumors with a molecular abnormality of interest, measured by cell viability one month after the tumor sample was collected.
3 secondary outcomes
Obtain spheroids that are phenotypically and genotypically stable.
Time frame: 1 month
Validate preclinical models to study the tumor response to innovative therapies.
Time frame: 1 month
Test the efficacy of molecules targeting variations identified in these tumors.
Time frame: 1 month
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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery or biopsy and Blood sample in people with Neoplasm Malignant, run by Centre Antoine Lacassagne at 1 site in France.
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 14 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 20 Jul 2026. 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 France. 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 Study coordinator (+33 04 92 03 14 76 ext. +33, DRCI-Promotion@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a cell culture technique for spheroids derived from fresh tumor samples collected among patients carrying a mutation of interest. (time frame: 1 month). 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 20 Jul 2026.