TumorTRUTHNCT06816160
TRU-Cut Biopsy in Tumor cHaracterisation
An observational study of Tumor, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
Tru-cut biopsy (TCB) is a minimally invasive method to get an adequate sample from the lesion in order to tailor the appropriate management avoiding unnecessary surgery. The aim of our trial is to evaluate the adequacy, accuracy and safety of the method related to the final histology as reference standard. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tumor
- What is being tested?
- tru-cut biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2024to 31 Jan 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with abdominopelvic tumor
Who may be able to join
None listed.
Who cannot join
- Considered by the investigator to be unsuitable for any treatment
- Early stage disease
- Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Filip Frühauf, MD. contact
Czechia1 site, 1 recruiting
- Recruiting
Department of Gynecology, Obstetrics and Neonatology of First Faculty of Medicine and General University Hospital in Prague
Prague, 12800
Renata Poncová, +420731573737, poncova.renata@gmail.com
Filip Frühauf, filip.fruehauf@vfn.cz
About this study
Official title: Tru-cut Biopsy in Tumor Characterisation
Tru-cut biopsy (TCB) is a minimally invasive method to get an adequate sample from the lesion in order to tailor the appropriate management avoiding unnecessary surgery. The aim of our trial is to evaluate the adequacy, accuracy and safety of the method related to the final histology as reference standard.
Read the detailed description
The primary endpoint is represented by the assessment of adequacy, accuracy and safety of the procedure in prospective settings. The secondary endpoint is to evaluate feasibility of immunohistochemistry (IHC), next generation sequencing (NGS) and tumor immunology in obtained samples by TCB and to assess the alterations of these tumor characteristics in relation to the treatment. The additional endpoint includes the effect of several variables (e.g. tumor origin, size of the tumor, presence of ascites, body mass index (BMI), biopsy site, biopsy approach - transvaginal, transrectal vs. transabdominal, status of the disease - the first diagnosis, the first and other recurrence or progression and previous treatment modality - chemotherapy, anti-angiogenic therapy, PARP inhibitor therapy, hormonal therapy, radiotherapy) on the outcome of the procedure (adequacy, accuracy and safety).
All patients indicated for tru-cut biopsy (including advanced stages of ovarian, endometrial or cervical cancers) in Gynecologic Oncology Center of the General University Hospital from February 2024 to January 2026 will be recruited. Furthermore, all patients with suspicious recurrence or progression of already known gynecologic malignancy based on the imaging methods will be recruited. The duration of recruitment is 3 years, and we expect 250 patients enrolled into the trial. Data will be assessed in relation to the patient characteristics, tumor/lesion characteristics, procedure specifications, histopathological characteristics and IHC/NGS/immunological characteristics, consequent biopsy/surgery and final histopathological results. All adverse events will be recorded. Moreover, patient related outcomes will be recorded within 72 hours after the procedure.
This prospective study could support our hypothesis that TCB is feasible and safe procedure with high adequacy and accuracy rate. It enables to get appropriate outcomes of IHC, NGS and immunology preoperatively. We expect that TCB is applicable and efficient in majority of recurrences/disease progressions, so it can be considered suitable technique for de novo biopsy. It can help us show the alterations of tumor characteristics after the previous treatment and can be used to select appropriate targeted therapy.
- Conditions
- Tumor
- Being tested
- tru-cut biopsy
- Keywords
- tumor, biopsy, tru-cut, core-cut, cancer, pelvic tumor
- Medical subject headings
- Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tru-cut biopsyProcedure or surgery
Also called core-cut biopsy
needle biopsy from the tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
The adequacy of samples obtained by TCB for histopathological examination (in %)
- The adequacy means the ability to determine the type of tumor (in %)
Measured: First data 31st of June 2025, definitive data 31st of January 2026
Secondary outcomes (3)
The adequacy of samples obtained by TCB for next-generation sequencing examination (in %)
- Adequacy of samples obtained by TCB for next-generation sequencing examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.
Measured: First data 31st of June 2025, definitive data 31st of January 2026
The adequacy of samples obtained by TCB for immunohistochemistry examination (in %)
- Adequacy of samples obtained by TCB for immunohistochemistry examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.
Measured: First data 31st of June 2025, definitive data 31st of January 2026
The adequacy of samples obtained by TCB for immunologic examination (in %)
- Adequacy of samples obtained by TCB for immunologic examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.
Measured: First data 31st of June 2025, definitive data 31st of January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Feb 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Poncová, General University Hospital, Prague
- Investigators
- David Cibula, prof., Study chair, Department of Gynecology, Obstetrics and Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816160
- Sponsor's protocol ID
- 10/23 Grant GIP
- Acronym
- TRUTH
- Status last verified
- Feb 2025
- First submitted
- 2 Mar 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Registration of subjects into the database using the REDCap (Research Electronic Data Capture, www.projectredcap.org) electronic data capture tool.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tru-cut Biopsy in Tumor Characterisation
- ClinicalTrials.gov ID
- NCT06816160
- Acronym / sponsor ID
- TRUTH / 10/23 Grant GIP
- Conditions
- Tumor
- Keywords
- tumor, biopsy, tru-cut, core-cut, cancer, pelvic tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Feb 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.
Tru-cut biopsy (TCB) is a minimally invasive method to get an adequate sample from the lesion in order to tailor the appropriate management avoiding unnecessary surgery. The aim of our trial is to evaluate the adequacy, accuracy and safety of the method related to the final histology as reference standard.
Detailed description
The primary endpoint is represented by the assessment of adequacy, accuracy and safety of the procedure in prospective settings. The secondary endpoint is to evaluate feasibility of immunohistochemistry (IHC), next generation sequencing (NGS) and tumor immunology in obtained samples by TCB and to assess the alterations of these tumor characteristics in relation to the treatment. The additional endpoint includes the effect of several variables (e.g. tumor origin, size of the tumor, presence of ascites, body mass index (BMI), biopsy site, biopsy approach - transvaginal, transrectal vs. transabdominal, status of the disease - the first diagnosis, the first and other recurrence or progression and previous treatment modality - chemotherapy, anti-angiogenic therapy, PARP inhibitor therapy, hormonal therapy, radiotherapy) on the outcome of the procedure (adequacy, accuracy and safety).
All patients indicated for tru-cut biopsy (including advanced stages of ovarian, endometrial or cervical cancers) in Gynecologic Oncology Center of the General University Hospital from February 2024 to January 2026 will be recruited. Furthermore, all patients with suspicious recurrence or progression of already known gynecologic malignancy based on the imaging methods will be recruited. The duration of recruitment is 3 years, and we expect 250 patients enrolled into the trial. Data will be assessed in relation to the patient characteristics, tumor/lesion characteristics, procedure specifications, histopathological characteristics and IHC/NGS/immunological characteristics, consequent biopsy/surgery and final histopathological results. All adverse events will be recorded. Moreover, patient related outcomes will be recorded within 72 hours after the procedure.
This prospective study could support our hypothesis that TCB is feasible and safe procedure with high adequacy and accuracy rate. It enables to get appropriate outcomes of IHC, NGS and immunology preoperatively. We expect that TCB is applicable and efficient in majority of recurrences/disease progressions, so it can be considered suitable technique for de novo biopsy. It can help us show the alterations of tumor characteristics after the previous treatment and can be used to select appropriate targeted therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with abdominopelvic tumor
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Considered by the investigator to be unsuitable for any treatment
- Early stage disease
- Age <18 years
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 |
|---|---|---|
| tru-cut biopsyAlso: core-cut biopsyneedle biopsy from the tumor | Procedure or surgery | – |
Primary outcome
The adequacy of samples obtained by TCB for histopathological examination (in %)
Time frame: First data 31st of June 2025, definitive data 31st of January 2026
1. The adequacy means the ability to determine the type of tumor (in %)
3 secondary outcomes
The adequacy of samples obtained by TCB for next-generation sequencing examination (in %)
Time frame: First data 31st of June 2025, definitive data 31st of January 2026
The adequacy of samples obtained by TCB for immunohistochemistry examination (in %)
Time frame: First data 31st of June 2025, definitive data 31st of January 2026
The adequacy of samples obtained by TCB for immunologic examination (in %)
Time frame: First data 31st of June 2025, definitive data 31st of January 2026
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 10 Feb 2025.
- Individual participant dataSharing planned: Yes. Registration of subjects into the database using the REDCap (Research Electronic Data Capture, www.projectredcap.org) electronic data capture tool.
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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.
Filip Frühauf, MD. contact
David Cibula, prof. study chair
Department of Gynecology, Obstetrics and Neonatology
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 Tumor, run by General University Hospital, Prague at 1 site in Czechia.
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 0 inclusion and 3 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 10 Feb 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 Czechia. 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 Renata Poncová, MD. (+420731573737, poncova.renata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adequacy of samples obtained by TCB for histopathological examination (in %) (time frame: First data 31st of June 2025, definitive data 31st of January 2026). 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 10 Feb 2025.