Cervical CancerMOLLYNCT06016868
Identification of a MOLecuLar Signature in Locally Advanced Cervical Cancer Patients
An observational study of Cervical Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Tumor tissue and Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix FIGO stage IIB and IIIC1.
Who may be able to join
- Age > 18 years
- Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- FIGO 2018 stage IIB and IIIC1[38]
- Treatment with exclusive chemoradiation including brachytherapy
- Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer
- Has radiographically evaluable disease, measurable per RECIST 1.1
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- Negative pregnancy test
- Adequate hematologic, renal, and hepatic functions, with following blood tests:
- Neutrophils > 1500/μL Platelets > 100.000/ μL Hemoglobin > 9 g/dL Serum creatinine < 1.8 mg/dL Total bilirubin < 3 mg/ dL LDH < 3x normal value GOT < 3x normal value GPT < 3x normal value ALP < 3 x normal value
Who cannot join
- Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc)
- Neo-adjuvant treatment
- Patients included in other clinical trials
- Patients refusing to sign informed consent
- Contraindications to radiotherapy
- Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Universitario Agostino Gemelli, IRCCS
Rome
Maria Gabriella F Ferrandina, PhD, 0630158667, mariagabriella.ferrandina@policlinicogemelli.it
About this study
Official title: Identification of a MOLecuLar Signature Predicting Radiosensitivity in Locally Advanced Cervical Cancer Patients (LACC) Treated With Exclusive radiochemotherapY: a Pilot Study
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.
Read the detailed description
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. Several biomarkers of cervical cancer radioresistance have been previously studied and proposed; however, none of these has been the subject to further clinical studies and implemented into clinical practice. Recently, a panel of three protein coding genes (ANXA2-NDRG1-STAT1) differently expressed in radiosensitive LACC patients compared with the radioresistant ones, has been proposed by our institution. The population of LACC patients included in a previous study was treated with neo-adjuvant CTRT followed by radical surgery. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.
- Conditions
- Cervical Cancer
- Being tested
- Tumor tissue, Blood sample
- 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.
Tumor tissueProcedure or surgery
Each newly diagnosed patient with LACC who meets the inclusion criteria will undergo cervical cancer biopsy either during the outpatient clinical examination or during examination during anesthetic. Part of the biopsy will be sent for histopathological analysis, while the remaining tissue will be embedded in OCT compound and immediately frozen at -80°C prior to transfer to biobank for subsequent analysis.
Blood sampleProcedure or surgery
Every patient will undergo a peripheral venous blood sample which will be processed to analyze the presence of the proteins codified by three RNA species (ANXA2-NDRG1-STAT1). This blood sample will be performed before starting the treatment with exclusive CTRT.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Not described Receives: Procedure: Tumor tissue; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the performance of the molecular signature.
To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016868
- Sponsor's protocol ID
- 5773
- Acronym
- MOLLY
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a MOLecuLar Signature Predicting Radiosensitivity in Locally Advanced Cervical Cancer Patients (LACC) Treated With Exclusive radiochemotherapY: a Pilot Study
- ClinicalTrials.gov ID
- NCT06016868
- Acronym / sponsor ID
- MOLLY / 5773
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 Aug 2023 (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.
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.
Detailed description
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. Several biomarkers of cervical cancer radioresistance have been previously studied and proposed; however, none of these has been the subject to further clinical studies and implemented into clinical practice. Recently, a panel of three protein coding genes (ANXA2-NDRG1-STAT1) differently expressed in radiosensitive LACC patients compared with the radioresistant ones, has been proposed by our institution. The population of LACC patients included in a previous study was treated with neo-adjuvant CTRT followed by radical surgery. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | – | Procedure: Tumor tissue, Procedure: Blood sample |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix FIGO stage IIB and IIIC1.
Key inclusion criteria (9 listed)
- Age > 18 years
- Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- FIGO 2018 stage IIB and IIIC1[38]
- Treatment with exclusive chemoradiation including brachytherapy
- Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer
Key exclusion criteria (6 listed)
- Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc)
- Neo-adjuvant treatment
- Patients included in other clinical trials
- Patients refusing to sign informed consent
- Contraindications to radiotherapy
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 |
|---|---|---|
| Tumor tissueEach newly diagnosed patient with LACC who meets the inclusion criteria will undergo cervical cancer biopsy either during the outpatient clinical examination or during examination during anesthetic. Part of the biopsy will be sent for histopathological analysis, while the remaining tissue will be embedded in OCT compound and immediately frozen at -80°C prior to transfer to biobank for subsequent analysis. | Procedure or surgery | Interventional |
| Blood sampleEvery patient will undergo a peripheral venous blood sample which will be processed to analyze the presence of the proteins codified by three RNA species (ANXA2-NDRG1-STAT1). This blood sample will be performed before starting the treatment with exclusive CTRT. | Procedure or surgery | Interventional |
Primary outcome
To test the performance of the molecular signature.
Time frame: 60 months
To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Maria F Ferrandina, PhD (0630158667, mariagabriella.ferrandina@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the performance of the molecular signature. (time frame: 60 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 30 Aug 2023.