Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Cancer Stage IB2, Cervical Cancer Stage IIa, Cervical Cancer Stage IB, Cervical Cancer Stage IIIA. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- RNA-sequencing [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- previous malignancies;
- previous systemic treatments;
- previous antibiotic treatment before surgery. Any antibiotic treatment must be stopped at least 3 weeks before surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- IRCCS National Cancer Institute "Regina Elena" — Roma
Identifiers
NCT: NCT07248878 · RS315/IRE/25