Cervical Cancer Stage IB2Cervical organNCT07248878
Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
An observational study of Cervical Cancer Stage IB2 and Cervical Cancer Stage IIa, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
A meta-analysis showed that neoadjuvant chemotherapy followed by radical hysterectomy reduces the risk of mortality by 35% compared to radiotherapy alone, with a 14% increase in five-year survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Stage IB2, Cervical Cancer Stage IIa, Cervical Cancer Stage IB
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2025to 26 Mar 2028
- 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: Patients with a suspected diagnosis of cervical cancer for whom a biopsy is indicated
Who may be able to join
- female over 18 years of age;
- suspected diagnosis of cervical cancer for which a biopsy is indicated according to standard clinical practice;
- Informed consent (study participation and data processing) given in writing personally and/or through the legal representative/guardian/support administrator/witness, before any study-specific procedure is performed.
Who cannot join
- previous malignancies;
- previous systemic treatments;
- previous antibiotic treatment before surgery. Any antibiotic treatment must be stopped at least 3 weeks before surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS National Cancer Institute "Regina Elena"
Roma, RM, 00144
Antonella Savarese, Medical Doctor, +39 0652666919, antonella.savarese@ifo.it
About this study
A meta-analysis showed that neoadjuvant chemotherapy followed by radical hysterectomy reduces the risk of mortality by 35% compared to radiotherapy alone, with a 14% increase in five-year survival. Unfortunately, however, approximately 30% of patients undergoing neoadjuvant chemotherapy are referred for adjuvant radiotherapy or chemoradiotherapy due to the presence of high recurrence risk factors after surgery, which results in a bi- or tri-modal treatment with very serious consequences in terms of toxicity. Infact, approximately 20% of patients treated with radiotherapy experience vaginal discomfort up to 3 years after completing treatment, with significant consequences for the women's quality of life. Therefore, on the one hand, it would be appropriate to identify new drugs that synergize with chemotherapy, reducing the need for adjuvant radiation; on the other, it could be useful to identify patients who could truly benefit from neoadjuvant treatment. To do this, it is necessary to have ex vivo biological models capable of simulating the complexity of the tumor environment and that can be used as a tool to investigate tumor response to specific treatments.
In this context, tumor organoids represent ideal alternative in vitro models, capable of preserving the characteristics of the original tumors, including their architecture and cell types present. They can be used as avatars for the selection of specific anticancer therapies and for the creation of patient biobanks.
Read the detailed description
The study involves the prospective recruitment of patients with suspected cervical cancer who undergo a biopsy at the Gynecological Oncology Unit of the Regina Elena Cancer Institute in Rome. Patients will be given an explanation, reading, and signing of the informed consent form.
They will undergo a biopsy and tissue sampling according to clinical practice during colposcopy.
A vaginal swab and blood sample will be taken before the biopsy. The tissue collected during the biopsy will be analyzed, and cases of cervical cancer with FIGO IB2, IB3-IIA2, and IIA1 or FIGO III will be selected for organoid culture.
If the analyzed tissue is negative for the presence of cancer (approximately 2% of cases), the patient will be considered a screening failure.
A portion of the tissue (approximately 1 cm) and the collected blood, only if their availability and adequacy are guaranteed for the purpose of conserving suitable material in an archive, will be sent to the IRE Translational Oncology Research Laboratories and used for the generation of organoids. The vaginal swab will be sent to the ISG Microbiology and Virology Laboratory for microbiome analysis.
The blood, tissue, and swab collected for patients who fail to respond will remain available to the IRE Anatomy Pathology Unit or will be biobanked for future studies related to this project.
- Conditions
- Cervical Cancer Stage IB2, Cervical Cancer Stage IIa, Cervical Cancer Stage IB, Cervical Cancer Stage IIIA
- Medical subject headings
- Uterine Cervical Neoplasms
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 |
|---|---|---|
| Patients with suspected cervical cancer | Patients with a suspected diagnosis of cervical cancer for whom a biopsy is indicated according to clinical practice who undergo a biopsy at the Gynecological Oncology Unit of the Regina Elena Cancer Institute in Rome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA-sequencing
DNA for WES profiling will be extracted from biopsy tissue and PDOs using the AllPrep kit.
The DNA/RNA/miRNA Universal Kit will be used to prepare organoid cultures.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start26 Mar 2025
- Primary completion26 Mar 2026 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Stage IB2Studies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Università di Verona, AOUI Verona Dipartimento di Ostetricia e Ginecologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248878
- Sponsor's protocol ID
- RS315/IRE/25
- Acronym
- Cervical organ
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
- ClinicalTrials.gov ID
- NCT07248878
- Acronym / sponsor ID
- Cervical organ / RS315/IRE/25
- Conditions
- Cervical Cancer Stage IB2, Cervical Cancer Stage IIa, Cervical Cancer Stage IB, Cervical Cancer Stage IIIA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Università di Verona, AOUI Verona Dipartimento di Ostetricia e Ginecologia
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 25 Nov 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.
A meta-analysis showed that neoadjuvant chemotherapy followed by radical hysterectomy reduces the risk of mortality by 35% compared to radiotherapy alone, with a 14% increase in five-year survival. Unfortunately, however, approximately 30% of patients undergoing neoadjuvant chemotherapy are referred for adjuvant radiotherapy or chemoradiotherapy due to the presence of high recurrence risk factors after surgery, which results in a bi- or tri-modal treatment with very serious consequences in terms of toxicity. Infact, approximately 20% of patients treated with radiotherapy experience vaginal discomfort up to 3 years after completing treatment, with significant consequences for the women's quality of life. Therefore, on the one hand, it would be appropriate to identify new drugs that synergize with chemotherapy, reducing the need for adjuvant radiation; on the other, it could be useful to identify patients who could truly benefit from neoadjuvant treatment. To do this, it is necessary to have ex vivo biological models capable of simulating the complexity of the tumor environment and that can be used as a tool to investigate tumor response to specific treatments.
In this context, tumor organoids represent ideal alternative in vitro models, capable of preserving the characteristics of the original tumors, including their architecture and cell types present. They can be used as avatars for the selection of specific anticancer therapies and for the creation of patient biobanks.
Detailed description
The study involves the prospective recruitment of patients with suspected cervical cancer who undergo a biopsy at the Gynecological Oncology Unit of the Regina Elena Cancer Institute in Rome. Patients will be given an explanation, reading, and signing of the informed consent form.
They will undergo a biopsy and tissue sampling according to clinical practice during colposcopy.
A vaginal swab and blood sample will be taken before the biopsy. The tissue collected during the biopsy will be analyzed, and cases of cervical cancer with FIGO IB2, IB3-IIA2, and IIA1 or FIGO III will be selected for organoid culture.
If the analyzed tissue is negative for the presence of cancer (approximately 2% of cases), the patient will be considered a screening failure.
A portion of the tissue (approximately 1 cm) and the collected blood, only if their availability and adequacy are guaranteed for the purpose of conserving suitable material in an archive, will be sent to the IRE Translational Oncology Research Laboratories and used for the generation of organoids. The vaginal swab will be sent to the ISG Microbiology and Virology Laboratory for microbiome analysis.
The blood, tissue, and swab collected for patients who fail to respond will remain available to the IRE Anatomy Pathology Unit or will be biobanked for future studies related to this project.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected cervical cancer | – | –Patients with a suspected diagnosis of cervical cancer for whom a biopsy is indicated according to clinical practice who undergo a biopsy at the Gynecological Oncology Unit of the Regina Elena Cancer Institute in Rome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a suspected diagnosis of cervical cancer for whom a biopsy is indicated
Key inclusion criteria (3 listed)
- female over 18 years of age;
- suspected diagnosis of cervical cancer for which a biopsy is indicated according to standard clinical practice;
- Informed consent (study participation and data processing) given in writing personally and/or through the legal representative/guardian/support administrator/witness, before any study-specific procedure is performed.
Key exclusion criteria (3 listed)
- previous malignancies;
- previous systemic treatments;
- previous antibiotic treatment before surgery. Any antibiotic treatment must be stopped at least 3 weeks before surgery.
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
RNA-sequencing
Time frame: 36 months
DNA for WES profiling will be extracted from biopsy tissue and PDOs using the AllPrep kit. The DNA/RNA/miRNA Universal Kit will be used to prepare organoid cultures.
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 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cervical Cancer Stage IB2
Active, not recruitingPhase 1
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma
Active, not recruitingPhase 3
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma
Active, not recruitingPhase 2
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
Localized Prostate Carcinoma, Locally Advanced Cervical Carcinoma
Active, not recruitingObservational study
Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
RecruitingObservational study
Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix
Cervical Large Cell Neuroendocrine Carcinoma, Cervical Neuroendocrine Carcinoma
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?
An observational study of Cervical Cancer Stage IB2 and Cervical Cancer Stage IIa, run by Regina Elena Cancer Institute 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 3 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 25 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 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 Antonella Savarese, Medical Doctor (+39 0652666919, antonella.savarese@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNA-sequencing (time frame: 36 months). 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 25 Nov 2025.