Cervical CancerRETRACENCT06771193
Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy
An observational study of Cervical Cancer and Locally Advanced Cervical Cancer, run by MSD Italia S.r.l. at 11 sites in Italy.
Trial summary
Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Locally Advanced Cervical Cancer, Recurrent Cervical Cancer
- How many people
- 200 participants
- Where
- 11 sitesItaly
- Study dates
- 17 Dec 2024to Dec 2025
- 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: All consecutive patients who attend the Oncologic Clinics authorized to participate in the study, with a record of diagnosed cervical cancer, treated between January 2018 and December 2021, will be eligible for inclusion in this study.
Who may be able to join
- Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF)
- Age ≥18 years
- Diagnosis of a cervical cancer
- Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease
- Any treatment received between January 2018 and December 2021 for advanced disease
Who cannot join
- Patients participating in a pharmacological clinical trial for the treatment of advanced disease
- Patients who participated in a clinical trial
- Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Italy11 sites, 11 recruiting
- Recruiting
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, Pordenone, 33081
- Recruiting
Oncologia Medica Policlinico Sant'Orsola Malpighi
Bologna, Bologna
- Recruiting
Ginecologia ed Ostetricia A.O. Cannizzaro
Catania, Catania, 95126
- Recruiting
Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino
Genova, Genova, 16132
- Not yet recruiting
UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima
Mestre, Venezia
- Recruiting
Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele
Milan, Milano, 20132
- Recruiting
Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X
Milan, Milano, 30159
- Recruiting
Oncologia A.O.U. di Modena - Policlinico
Modena, Modena, 41124
- Recruiting
U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
Naples, Napoli, 80131
- Recruiting
UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Napoli, 80138
- Recruiting
U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli
Roma, Roma, 00168
About this study
Official title: RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy
Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.
Read the detailed description
This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.
Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).
Disease will be defined as follow:
- Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging)
- Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26)
- Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.
- Conditions
- Cervical Cancer, Locally Advanced Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)
Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Measured: Retrospective data capture from Jan 2018 to Dec 2021
The proportion of patient with recurrence or dead after treatment and remission (%)
Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Measured: Retrospective data capture from Jan 2018 to Dec 2021
Median time from remission to recurrence
The study aim is to describe the time from curative intervention to recurrence (for patients who had a curative surgery).
Time to recurrence will be calculated and represented using Kaplan-Meier curves and summarized using median with 95% confidence interval.
Measured: Retrospective data capture from Jan 2018 to Dec 2021
Number of lines of treatment
The aim of this analysis is to describe patients' treatment patterns in LA or R/M Cervical Cancer considering the high heterogeneity of treatment options in clinical setting and the lack of real-world data in Italy.
Measured: Retrospective data capture from Jan 2018 to Dec 2021
The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC
Healthcare services for the present study include drug costs, general hospital costs (based on number of patient admissions and days of hospitalization, outpatients' visits, emergency access), specialist consultations and concomitant medications related to safety issue, radiological procedures, laboratory exams.
Measured: Retrospective data capture from Jan 2018 to Dec 2021
Secondary outcomes (4)
The proportion of patients who undergone screening program (%)
Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Measured: Retrospective data capture from Jan 2018 to Dec 2021
HPV subtype typization, if available
Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Measured: Retrospective data capture from Jan 2018 to Dec 2021
History of HPV related lesions (CIN 2+ lesion)
Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Measured: Retrospective data capture from Jan 2018 to Dec 2021
The proportion of patients with PD-L1 >1% and >50% (%)
To describe the expression profile of PD-L1 (if available in archive pathology reports).
Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Measured: Retrospective data capture from Jan 2018 to Dec 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start17 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 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.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MSD Italia S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771193
- Sponsor's protocol ID
- NIS102062
- Acronym
- RETRACE
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy
- ClinicalTrials.gov ID
- NCT06771193
- Acronym / sponsor ID
- RETRACE / NIS102062
- Conditions
- Cervical Cancer, Locally Advanced Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MSD Italia S.r.l.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 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.
Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.
Detailed description
This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.
Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).
Disease will be defined as follow:
- Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging)
- Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26)
- Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who attend the Oncologic Clinics authorized to participate in the study, with a record of diagnosed cervical cancer, treated between January 2018 and December 2021, will be eligible for inclusion in this study.
Key inclusion criteria (5 listed)
- Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF)
- Age ≥18 years
- Diagnosis of a cervical cancer
- Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease
- Any treatment received between January 2018 and December 2021 for advanced disease
Key exclusion criteria (3 listed)
- Patients participating in a pharmacological clinical trial for the treatment of advanced disease
- Patients who participated in a clinical trial
- Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs
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
The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
The proportion of patient with recurrence or dead after treatment and remission (%)
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Median time from remission to recurrence
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
The study aim is to describe the time from curative intervention to recurrence (for patients who had a curative surgery). Time to recurrence will be calculated and represented using Kaplan-Meier curves and summarized using median with 95% confidence interval.
Number of lines of treatment
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
The aim of this analysis is to describe patients' treatment patterns in LA or R/M Cervical Cancer considering the high heterogeneity of treatment options in clinical setting and the lack of real-world data in Italy.
The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
Healthcare services for the present study include drug costs, general hospital costs (based on number of patient admissions and days of hospitalization, outpatients' visits, emergency access), specialist consultations and concomitant medications related to safety issue, radiological procedures, laboratory exams.
4 secondary outcomes
The proportion of patients who undergone screening program (%)
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
HPV subtype typization, if available
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
History of HPV related lesions (CIN 2+ lesion)
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
The proportion of patients with PD-L1 >1% and >50% (%)
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
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 2025.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
11 sites 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 and Locally Advanced Cervical Cancer, run by MSD Italia S.r.l. at 11 sites 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 5 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Stefania Lopez (+39 03626331, info.studiclinici@opisresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%) (time frame: Retrospective data capture from Jan 2018 to Dec 2021). The study lists 5 primary outcomes in all. 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 2025.