Cancer-associated ThrombosisGynCATNCT06284343
The Gynecological Cancer Associated Thrombosis (GynCAT) Study
An observational study of Cancer-associated Thrombosis and Venous Thromboembolism, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment, aiming at development and validation of a Risk Assessment Model (RAM) for Venous Thromboembolism (VTE) in this specific population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer-associated Thrombosis, Venous Thromboembolism, Gynecologic Cancer
- What is being tested?
- Anticoagulant
- How many people
- 1,800 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2024to 30 Sep 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study population will consist of subsequent patients prospectively enrolled at the time of prescription of a new line of systemic antineoplastic treatment for a gynecologic oncological disease, defined as ovarian, tubal, uterine, cervical, vaginal, or vulvar neoplasm. Patients will be recruited in the setting of the Gynecologic Oncology Day Hospital and evaluated by the Thrombosis Clinic of the Agostino Gemelli University Polyclinic Foundation I.R.C.C.S. in Rome.
Who may be able to join
- Female sex;
- Diagnosis of gynecologic neoplasm (ovarian, tubal, uterine, cervical, vaginal, vulvar neoplasm);
- Planned new line of systemic antineoplastic treatment;
- Age of 18 years or older;
- Accordance of Informed Consent.
Who cannot join
- Pregnant or breastfeeding women;
- Indication to receive therapeutic dose anticoagulant therapy (e.g., atrial fibrillation, mechanical heart valve);
- Diagnosis of symptomatic VTE at the time of screening for enrollment.
Trial locations and contacts
1 site in 1 country.
Paolo Santini, MD contact
Italy1 site, 1 recruiting
- Recruiting
Agostino Gemelli University Polyclinic Foundation IRCCS
Rome, 00168
Roberto Pola, PhD; MD, +39 0630157075, roberto.pola@policlinicogemelli.it
Paolo Santini, MD, paolo.santini@guest.policlinicogemelli.it
About this study
Official title: Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study
GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment, aiming at development and validation of a Risk Assessment Model (RAM) for Venous Thromboembolism (VTE) in this specific population.
Read the detailed description
Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk.
GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded.
The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population.
The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine \& Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes.
In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population.
- Conditions
- Cancer-associated Thrombosis, Venous Thromboembolism, Gynecologic Cancer, Ovarian Cancer, Cervix Cancer, Endometrial Cancer
- Being tested
- Anticoagulant
- Keywords
- Thrombosis, Venous thromboembolism, Cancer, Ovarian Cancer, Vaginal Cancer, Endometrial Cancer, Gynecologic Cancer
- Medical subject headings
- Venous Thromboembolism, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Vaginal Neoplasms, Thrombosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulantDrug
Also called Low Molecular Weight Heparin, Apixaban, Rivaroxaban
Prescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment | Study population will consist of subsequent patients prospectively enrolled at the time of prescription of a new line of systemic antineoplastic treatment for a gynecologic oncological disease, defined as ovarian, tubal, uterine, cervical, vaginal, or vulvar neoplasm Receives: Drug: Anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Venous thromboembolism
Venous Thromboembolism (VTE) diagnosis will be assigned in case of objective confirmation by venous duplex ultrasonography and/or contrast enhanced CT and/or MRI and/or ventilation/perfusion SPECT.
In case of death during follow-up, clinical documentation and/or autopsy findings, if available, will be reviewed to assess for the presence of a possible diagnosis of fatal pulmonary embolism.
VTE events will be independently judged by an external committee, constituted by Angiology and Radiology experts, blinded to patients' clinical history and laboratory parameters. Incidentally detected VTE events will be considered as events, provided their eligibility by the aforementioned external committee.
Measured: Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively.
Secondary outcomes (1)
Number of Participants with Bleeding events (major and clinically relevant non-major bleeding)
After acquisition and review of the clinical documentation related to a hemorrhagic event, bleeding will be assigned if requirements for major or clinically relevant nonmajor bleeding are met, as defined by the International Society on Thrombosis and Haemostasis (ISTH)
Measured: Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-associated ThrombosisStudies 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
- 1,800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Umberto Veronesi
- Responsible party
- Principal investigator, Pola Roberto, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Roberto Pola, PhD; MD, Principal investigator, Agostino Gemelli University Polyclinic Foundation IRCCSPaolo Santini, MD, Study chair, Agostino Gemelli University Polyclinic Foundation IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284343
- Sponsor's protocol ID
- 6414
- Acronym
- GynCAT
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study
- ClinicalTrials.gov ID
- NCT06284343
- Acronym / sponsor ID
- GynCAT / 6414
- Conditions
- Cancer-associated Thrombosis, Venous Thromboembolism, Gynecologic Cancer, Ovarian Cancer, Cervix Cancer, Endometrial Cancer
- Keywords
- Thrombosis, Venous thromboembolism, Cancer, Ovarian Cancer, Vaginal Cancer, Endometrial Cancer, Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Fondazione Umberto Veronesi
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Feb 2024 (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.
GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment, aiming at development and validation of a Risk Assessment Model (RAM) for Venous Thromboembolism (VTE) in this specific population.
Detailed description
Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk.
GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded.
The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population.
The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine \& Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes.
In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment | – | Drug: AnticoagulantStudy population will consist of subsequent patients prospectively enrolled at the time of prescription of a new line of systemic antineoplastic treatment for a gynecologic oncological disease, defined as ovarian, tubal, uterine, cervical, vaginal, or vulvar neoplasm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist of subsequent patients prospectively enrolled at the time of prescription of a new line of systemic antineoplastic treatment for a gynecologic oncological disease, defined as ovarian, tubal, uterine, cervical, vaginal, or vulvar neoplasm. Patients will be recruited in the setting of the Gynecologic Oncology Day Hospital and evaluated by the Thrombosis Clinic of the Agostino Gemelli University Polyclinic Foundation I.R.C.C.S. in Rome.
Key inclusion criteria (5 listed)
- Female sex;
- Diagnosis of gynecologic neoplasm (ovarian, tubal, uterine, cervical, vaginal, vulvar neoplasm);
- Planned new line of systemic antineoplastic treatment;
- Age of 18 years or older;
- Accordance of Informed Consent.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women;
- Indication to receive therapeutic dose anticoagulant therapy (e.g., atrial fibrillation, mechanical heart valve);
- Diagnosis of symptomatic VTE at the time of screening for enrollment.
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 |
|---|---|---|
| AnticoagulantAlso: Low Molecular Weight Heparin, Apixaban, RivaroxabanPrescription of pharmacological thromboprophylaxis according to current clinical practice and international guidelines recommendation | Drug | Patients affected by Gynecologic Cancer undergoing systemic antineoplastic treatment |
Primary outcome
Number of Participants with Venous thromboembolism
Time frame: Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively.
Venous Thromboembolism (VTE) diagnosis will be assigned in case of objective confirmation by venous duplex ultrasonography and/or contrast enhanced CT and/or MRI and/or ventilation/perfusion SPECT. In case of death during follow-up, clinical documentation and/or autopsy findings, if available, will be reviewed to assess for the presence of a possible diagnosis of fatal pulmonary embolism. VTE events will be independently judged by an external committee, constituted by Angiology and Radiology experts, blinded to patients' clinical history and laboratory parameters. Incidentally detected VTE events will be considered as events, provided their eligibility by the aforementioned external committee.
1 secondary outcome
Number of Participants with Bleeding events (major and clinically relevant non-major bleeding)
Time frame: Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer-associated Thrombosis
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Not yet recruitingObservational study
Construction and Multicenter External Validation of an Early Warning Model for Asymptomatic PICC-related Upper Extremity Venous Thrombosis in Cancer Patients Based on LASSO-XGBoost
PICC-associated Thrombosis
Not yet recruitingPhase 4
Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
Venous Thromboembolism, Active Cancer
RecruitingPhase 4
Statins to Prevent Cancer Associated Blood Clots
Venous Thromboembolism, Cancer
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.
Paolo Santini, MD contact
Roberto Pola, PhD; MD principal investigator
Agostino Gemelli University Polyclinic Foundation IRCCS
Paolo Santini, MD study chair
Agostino Gemelli University Polyclinic Foundation IRCCS
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 Cancer-associated Thrombosis and Venous Thromboembolism, 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 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Roberto Pola, PhD; MD (+39 0630157075, roberto.pola@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Venous thromboembolism (time frame: Follow-up will continue until one of the following censoring events will occur: • EpPatients will be evaluated with one in-person medical visit at enrollment, followed by one telephone visit and one in-person examination at 6 and 12 months, respectively.). 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 19 Sep 2024.