Gynecologic CancerG-AYANCT06594471
Comprehensive Assessment of Clinical Characteristics and Outcomes of Gemelli Adolescents and Young Adults
An observational study of Gynecologic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The Adolescent and Young Adults cancer population encompass patients diagnosed with oncological disease at the age of 15-39 years. Although 86% of these patients become long-term cancer survivors, studies have shown that these survival rates lag behind to those of younger and older patients. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Questionnaire on late-term physical effects, Questionnaire on sexual and reproductive health outcomes and Questionnaire on psychological outcomes
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2024to 31 Mar 2040
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients will be included who are diagnosed with gynecological cancer of any tumor type at the age of 15-39 years and have been treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital in Rome, Italy.
Who may be able to join
- Gynecological cancer types include but are not limited to the following:
- Ovarian cancer - borderline tumors with invasive peritoneal implants, epithelial carcinoma (endometrioid, clear cell, high-grade serous, low-grade serous, mucinous, undifferentiated), germ cell tumor (dysgerminoma, immature teratomas, yolk sac tumors, embryonal carcinomas, carcinoid tumors), sex cord stromal tumor (gynandroblastoma, granulosa cell tumor, Sertoli-Leydig cell tumor, steroid cell tumor)
- Cervical cancer - squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, carcinoma in situ with stromal microinvasion (to be considered as microinvasive carcinoma), other
- Endometrial cancer - endometrioid, papillary serous, clear cell, carcinosarcoma
- Sarcoma - uterine sarcoma (incl. leiomyosarcoma, endometrial stromal sarcoma, adenosarcoma)
- Gestational trophoblastic neoplasms - invasive mole, choriosarcoma, placental site trophoblastic tumor, epithelioid trophoblastic tumor, other
- Vulvar-vaginal cancer - squamous cell carcinoma, M. Paget, other
Who cannot join
- Mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent
- Patients who do not provide informed consent on data collection and storage for scientific purposes
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
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC GINECOLOGIA ONCOLOGICA
Roma, 00168
Giovanni Scambia, +3930155701, giovanni.scambia@policlinicogemelli.it
Inge Peters, ingetheodoraanne.peters@guest.policlinicogemelli.it
About this study
Official title: Comprehensive Assessment of Characteristics and Outcomes of Gemelli Adolescents and Young Adults Diagnosed With Gynecological Cancer
The Adolescent and Young Adults cancer population encompass patients diagnosed with oncological disease at the age of 15-39 years. Although 86% of these patients become long-term cancer survivors, studies have shown that these survival rates lag behind to those of younger and older patients. The underlying reason for this discrepancy is, however, yet poorly understood. Furthermore, these patients may be more often confronted with late effects due to their disease and/or anticancer treatment. Knowledge on Adolescent and Young Adults diagnosed with gynecological cancer at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital in Rome, Italy, is currently lacking and is needed to deliver these patients the best possible care, tailored to their disease characteristics and specific needs.
The primary objective of this monocenter observational study is to determine the number of Gemelli Adolescent and Young Adults diagnosed with gynecological cancer and their clinical characteristics. Secondary objectives will be to determine their oncological, late-term physical effects, sexual and reproductive health, psychological and social outcomes. Tertiary outcomes will be to compare the clinical characteristics and oncological outcomes of Gemelli Adolescents and Young Adults to patients beyond this age-specific cohort who have been treated during the same study period.
Read the detailed description
Clinical, diagnosis and treatment characteristics will be determined. In addition, oncological (e.g., disease-free and overall survival), late-term physical (e.g., cardiovascular, second primary tumor), sexual and reproductive health (e.g., body image, sexual functioning, fertility preservation, pregnancy rate, premature ovarian insufficiency), psychological (e.g., anxiety and depression) and social (e.g. (un)employment, financial toxicity) outcomes will be determined.
- Conditions
- Gynecologic Cancer
- Being tested
- Questionnaire on late-term physical effects, Questionnaire on sexual and reproductive health outcomes, Questionnaire on psychological outcomes, Questionnaire on social outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on late-term physical effectsOther
Patients will be asked to indicate any potential late-term physical effects following cancer treatment: neurocognitive, auditory, ocular, oral/dental, dermatologic, cardiovascular, pulmonary, gastro-intestinal, urinary tract, genital, endocrine/metabolic, musculoskeletal, neurological, immune disorders and occurrence of any subsequent malignant neoplasms.
Questionnaire on sexual and reproductive health outcomesOther
Patients will be asked to complete the following questionnaires: Body Appreciation Scale-2 (BAS-2), Body Image Scale (BIS), EORTC QLQ-SH22, Body Image Scale in Gynecological Cancer (SABIS-G). Patients who underwent a fertility-sparing procedure will be asked to fill out the Reproductive Concerns after Cancer (RCAC) and Decision Regret Scale (DRS), whereas those who experienced iatrogenic menopause will complete the MENQOL questionnaire to assess menopause-related quality of life.
Questionnaire on psychological outcomesOther
Patients will be asked to complete the following questionaires: EORTC QLQ-C30, Clinical outcomes in Routine Evaluation (CORE-OM), Ten Item Personality Inventory (TIPI), Hospital Anxiety and Depression Scale (HADS), General Self-Efficacy (GSE) Scale, Mini-Mental Adjustment to Cancer (Mini-MAC), Cancer Worry Scale (CWS), Multidimensional Scale of Perceived Social Support (MSPSS), the Patient Health Engagement scale and the Supportive Care Needs Survey-Short Form (SCNS-SF34).
Questionnaire on social outcomesOther
Patients will be asked to complete the following questionaires: Medical Consumption Questionnaire (iMCQ), Productivity Cost Questionnaire (iPCQ) and the Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
The number of Adolescents and Young Adults diagnosed with gynecological cancer who receive treatment at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital during a five-year period and their clinical characteristics, i.e., demographics, diagnosis, imaging, treatment and clinical trial participation.
Measured: 10 years
Secondary outcomes (39)
Survival outcomes
Oncological outcomes, i.e., progression-free survival, disease-specific and overall survival
Measured: 10 years
Late-term physical effects - neurocognitive disorders
Number of patients who developed neurocognitive disorders
Measured: 10 years
Late-term physical effects - auditory disorders
Number of patients who developed auditory disorders
Measured: 10 years
Late-term physical effects - ocular disorders
Number of patients who developed ocular disorders
Measured: 10 years
Late-term physical effects - oral/dental disorders
Number of patients who developed oral/dental disorders
Measured: 10 years
Late-term physical effects - dermatological disorders
Number of patients who developed dermatological disorders
Measured: 10 years
Late-term physical effects - cardiovascular disorders
Number of patients who developed cardiovascular disorders
Measured: 10 years
Late-term physical effects - pulmonary disorders
Number of patients who developed pulmonary disorders
Measured: 10 years
Late-term physical effects - gastro-intestinal disorders
Number of patients who developed gastro-intestinal disorders
Measured: 10 years
Late-term physical effects - urinary tract disorders
Number of patients who developed urinary tract disorders
Measured: 10 years
Late-term physical effects - genital disorders
Number of patients who developed genital disorders
Measured: 10 years
Late-term physical effects - endocrine/metabolic disorders
Number of patients who developed endocrine/metabolic disorders
Measured: 10 years
Late-term physical effects - musculoskeletal disorders
Number of patients who developed musculoskeletal disorders
Measured: 10 years
Late-term physical effects - neurological disorders
Number of patients who developed neurological disorders
Measured: 10 years
Late-term physical effects - immune disorders
Number of patients who developed immune disorders
Measured: 10 years
Late-term physical effects - subsequent malignant neoplasms
Number of patients who developed subsequent malignant neoplasms
Measured: 10 years
Sexual outcomes - Body Appreciation Scale-2
The 10-item BAS-2 uses a 5-point Likert scale with responses ranging from 1 (never) to 5 (always) and has demonstrated positive ties between body appreciation and one's psychological well-being (e.g., self-esteem, optimism, positive affect, and negative links with body surveillance, body shame, and body dissatisfaction)
Measured: 10 years
Sexual outcomes - Sexual Adjustment and Body Image Scale in Gynecological cancer (SABIS-G)
The Sexuality and Body Image Scale for women with Gynecological cancer (SABIS-G) consists of a 7-item measure with 3 items related to body image and 4 related to sexual adjustment. To score the SABIS-G each variable is scored from 1 to 5, with 5 as the best outcome. The body image subscale sum ranges from 3 to 15 and the sexual adjustment subscale sum ranges from 4 to 20.
Measured: 10 years
Sexual outcomes - Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain over the past 30 days. Each domain is scored from 0 to 5 with 5 as the best outcome.
Measured: 10 years
Sexual outcomes - EORTC Sexual Health (SH-22) questionnaire
The 22-item EORTC sexual health questionnaire developed to assess sexual health in male and female cancer patients and cancer survivors and ranges from 1 to 4 with 4 as the best outcome.
Measured: 10 years
Reproductive outcomes - fertility preservation
Number of patients who underwent fertility preservation, number of pregnancies achieved, number of live births achieved
Measured: 10 years
Reproductive outcomes - Decision Regret Scale (DRS)
The Decision Regret Scale (DRS) measures distress or 'remorse' after a health care decision and ranges from 1 to 5 with 5 as the worst outcome
Measured: 10 years
Reproductive outcomes - Reproductive Concerns After Cancer (RCAC) scale
The Reproductive Concerns After Cancer (RCAC) scale is a multidimensional measure of possible reproductive concerns of women following cancer diagnosis and treatment, yielding six subscale scores: fertility potential, partner disclosure of fertility status, child's health, personal health, acceptance of possible infertility, and becoming pregnant. The scale ranges from 1 to 5 with 5 as the worst outcome.
Measured: 10 years
Reproductive outcomes - Iatrogenic menopause
Type of treatments received related to iatrogenic menopause
Measured: 10 years
Reproductive outcomes - Menopause Quality of Life (MenQoL) questionnaire
The extent of menopause-related disturbances patients experienced, ranging from 0 to 6 with 6 as the worst outcome.
Measured: 10 years
Psychological outcomes - EORTC-C30 general quality of life questionnaire
This is a 30-item HRQoL questionnaire consisting of five functional scales (physical, role, cognitive, emotional, and social), a global quality-of-life scale, three symptom scales (fatigue, pain, nausea and vomiting) and a number of single items assessing common symptoms (dyspnea, loss of appetite, sleep disturbance, constipation, and diarrhea) and the perceived financial impact of the disease. It has 28 items ranging from 1 to 4 with 4 as the worst outcome and two items ranging from 0 to 7 with 7 as the best outcome.
Measured: 10 years
Psychological outcomes - Clinical outcomes in Routine Evaluation (CORE-OM)
Clinical outcomes in Routine Evaluation (CORE-OM) is a 34-item evaluation covering four domains: wellbeing, problems, functioning and risk. The score ranges from 0 to 4 with 4 as the worst outcome.
Measured: 10 years
Psychological outcomes - Ten Item Personality Inventory (TIPI)
Ten Item Personality Inventory (TIPI) is a 10-item measure of the Big-Five dimensions (extraversion, agreeableness, conscientiousness, emotional stability, openness).
Measured: 10 years
Psychological outcomes - Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with 7 items each for assessing symptoms of anxiety and depression, each item ranging from 0 to 3. Summing up this items a final assesment is obtained: 0-7 = Normal, 8-10 = Borderline abnormal (borderline case),11-21 = Abnormal (case).
Measured: 10 years
Psychological outcomes - Distress thermometer
The distress thermometer is one-item measure that assesses the level of distress patients have experienced in the preceding week and uses a 0-10 rating scale.
Measured: 10 years
Psychological outcomes - General Self-Efficacy (GSE) Scale
The General Self-Efficacy (GSE) Scale consists of ten items to examine the patient's problem-solving abilities. The scale ranges from 1 to 4 with 4 as the best outcome.
Measured: 10 years
Psychological outcomes - Mini-Mental Adjustment to Cancer (Mini-MAC)
The Mini-Mental Adjustment to Cancer (Mini-MAC) scale examines the patients' attitudes towards cancer using a 4-point Likert scale.
Measured: 10 years
Psychological outcomes - Cancer Worry Scale (CWS)
The 8-item Cancer Worry Scale (CWS) assesses concerns regarding cancer diagnosis using a 4-point Likert scale with 4 as the worst outcome.
Measured: 10 years
Psychological outcomes - Multidimensional Scale of Perceived Social Support (MSPSS)
The 12-item Multidimensional Scale of Perceived Social Support (MSPSS) examines to what extent the patient has received support from family members, relatives and friends, ranging from 1 to 7 with 7 as the best outcome.
Measured: 10 years
Psychological outcomes - Patient Health Engagement scale
The 5-item Patient Health Engagement scale examines to what extent the patient is able to manage her disease ranging from 0-7 with 7 as the best outcome.
Measured: 10 years
Psychological outcomes - Supportive Care Needs Survey-Short Form (SCNS-SF34)
The Supportive Care Needs Survey-Short Form (SCNS-SF34) is a 34-item, validated measure of cancer-specific perceived needs across five domains: psychological, health systems and information, physical and daily living, patient care and support, and sexuality. Patients rate their level of need for help in the past month, scale ranges from 1 (no need/not applicable) to 5 (high need).
Measured: 10 years
Social outcomes - Medical Consumption Questionnaire (iMCQ)
Number of occurring contacts with health care providers and time off from work for doctors' visits.
Measured: 10 years
Social outcomes - Productivity Cost Questionnaire (iPCQ)
Productivity Cost Questionnaire (iPCQ) will be used to evaluate the impact of disease on the productivity of a person
Measured: 10 years
Social outcomes - Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool
The Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool represents a patient-reported outcome measure that describes the financial distress experienced by cancer patients using a 5-point Likert scale ranging from 0 to 4 with 4 as the worst outcome.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024 (estimated)
- Primary completion30 Sep 2039 (estimated)
- Study completion31 Mar 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Scambia, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594471
- Sponsor's protocol ID
- ID 6432
- Acronym
- G-AYA
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Comprehensive Assessment of Characteristics and Outcomes of Gemelli Adolescents and Young Adults Diagnosed With Gynecological Cancer
- ClinicalTrials.gov ID
- NCT06594471
- Acronym / sponsor ID
- G-AYA / ID 6432
- Conditions
- Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 9 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2039 (estimated)
- Study completion
- 31 Mar 2040 (estimated)
- First posted
- 19 Sep 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.
The Adolescent and Young Adults cancer population encompass patients diagnosed with oncological disease at the age of 15-39 years. Although 86% of these patients become long-term cancer survivors, studies have shown that these survival rates lag behind to those of younger and older patients. The underlying reason for this discrepancy is, however, yet poorly understood. Furthermore, these patients may be more often confronted with late effects due to their disease and/or anticancer treatment. Knowledge on Adolescent and Young Adults diagnosed with gynecological cancer at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital in Rome, Italy, is currently lacking and is needed to deliver these patients the best possible care, tailored to their disease characteristics and specific needs.
The primary objective of this monocenter observational study is to determine the number of Gemelli Adolescent and Young Adults diagnosed with gynecological cancer and their clinical characteristics. Secondary objectives will be to determine their oncological, late-term physical effects, sexual and reproductive health, psychological and social outcomes. Tertiary outcomes will be to compare the clinical characteristics and oncological outcomes of Gemelli Adolescents and Young Adults to patients beyond this age-specific cohort who have been treated during the same study period.
Detailed description
Clinical, diagnosis and treatment characteristics will be determined. In addition, oncological (e.g., disease-free and overall survival), late-term physical (e.g., cardiovascular, second primary tumor), sexual and reproductive health (e.g., body image, sexual functioning, fertility preservation, pregnancy rate, premature ovarian insufficiency), psychological (e.g., anxiety and depression) and social (e.g. (un)employment, financial toxicity) outcomes will be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients will be included who are diagnosed with gynecological cancer of any tumor type at the age of 15-39 years and have been treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital in Rome, Italy.
Key inclusion criteria (7 listed)
- Ovarian cancer - borderline tumors with invasive peritoneal implants, epithelial carcinoma (endometrioid, clear cell, high-grade serous, low-grade serous, mucinous, undifferentiated), germ cell tumor (dysgerminoma, immature teratomas, yolk sac tumors, embryonal carcinomas, carcinoid tumors), sex cord stromal tumor (gynandroblastoma, granulosa cell tumor, Sertoli-Leydig cell tumor, steroid cell tumor)
- Cervical cancer - squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, carcinoma in situ with stromal microinvasion (to be considered as microinvasive carcinoma), other
- Endometrial cancer - endometrioid, papillary serous, clear cell, carcinosarcoma
- Sarcoma - uterine sarcoma (incl. leiomyosarcoma, endometrial stromal sarcoma, adenosarcoma)
- Gestational trophoblastic neoplasms - invasive mole, choriosarcoma, placental site trophoblastic tumor, epithelioid trophoblastic tumor, other
Key exclusion criteria (2 listed)
- Mentally disabled or patients with significantly altered mental status that would prohibit understanding and giving informed consent
- Patients who do not provide informed consent on data collection and storage for scientific purposes
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 |
|---|---|---|
| Questionnaire on late-term physical effectsPatients will be asked to indicate any potential late-term physical effects following cancer treatment: neurocognitive, auditory, ocular, oral/dental, dermatologic, cardiovascular, pulmonary, gastro-intestinal, urinary tract, genital, endocrine/metabolic, musculoskeletal, neurological, immune disorders and occurrence of any subsequent malignant neoplasms. | Other | – |
| Questionnaire on sexual and reproductive health outcomesPatients will be asked to complete the following questionnaires: Body Appreciation Scale-2 (BAS-2), Body Image Scale (BIS), EORTC QLQ-SH22, Body Image Scale in Gynecological Cancer (SABIS-G). Patients who underwent a fertility-sparing procedure will be asked to fill out the Reproductive Concerns after Cancer (RCAC) and Decision Regret Scale (DRS), whereas those who experienced iatrogenic menopause will complete the MENQOL questionnaire to assess menopause-related quality of life. | Other | – |
| Questionnaire on psychological outcomesPatients will be asked to complete the following questionaires: EORTC QLQ-C30, Clinical outcomes in Routine Evaluation (CORE-OM), Ten Item Personality Inventory (TIPI), Hospital Anxiety and Depression Scale (HADS), General Self-Efficacy (GSE) Scale, Mini-Mental Adjustment to Cancer (Mini-MAC), Cancer Worry Scale (CWS), Multidimensional Scale of Perceived Social Support (MSPSS), the Patient Health Engagement scale and the Supportive Care Needs Survey-Short Form (SCNS-SF34). | Other | – |
| Questionnaire on social outcomesPatients will be asked to complete the following questionaires: Medical Consumption Questionnaire (iMCQ), Productivity Cost Questionnaire (iPCQ) and the Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire. | Other | – |
Primary outcome
Clinical outcomes
Time frame: 10 years
The number of Adolescents and Young Adults diagnosed with gynecological cancer who receive treatment at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS hospital during a five-year period and their clinical characteristics, i.e., demographics, diagnosis, imaging, treatment and clinical trial participation.
39 secondary outcomes
Survival outcomes
Time frame: 10 years
Late-term physical effects - neurocognitive disorders
Time frame: 10 years
Late-term physical effects - auditory disorders
Time frame: 10 years
Late-term physical effects - ocular disorders
Time frame: 10 years
Late-term physical effects - oral/dental disorders
Time frame: 10 years
Late-term physical effects - dermatological disorders
Time frame: 10 years
Late-term physical effects - cardiovascular disorders
Time frame: 10 years
Late-term physical effects - pulmonary disorders
Time frame: 10 years
Late-term physical effects - gastro-intestinal disorders
Time frame: 10 years
Late-term physical effects - urinary tract disorders
Time frame: 10 years
Late-term physical effects - genital disorders
Time frame: 10 years
Late-term physical effects - endocrine/metabolic disorders
Time frame: 10 years
Late-term physical effects - musculoskeletal disorders
Time frame: 10 years
Late-term physical effects - neurological disorders
Time frame: 10 years
Late-term physical effects - immune disorders
Time frame: 10 years
Late-term physical effects - subsequent malignant neoplasms
Time frame: 10 years
Sexual outcomes - Body Appreciation Scale-2
Time frame: 10 years
Sexual outcomes - Sexual Adjustment and Body Image Scale in Gynecological cancer (SABIS-G)
Time frame: 10 years
Sexual outcomes - Female Sexual Function Index (FSFI)
Time frame: 10 years
Sexual outcomes - EORTC Sexual Health (SH-22) questionnaire
Time frame: 10 years
Reproductive outcomes - fertility preservation
Time frame: 10 years
Reproductive outcomes - Decision Regret Scale (DRS)
Time frame: 10 years
Reproductive outcomes - Reproductive Concerns After Cancer (RCAC) scale
Time frame: 10 years
Reproductive outcomes - Iatrogenic menopause
Time frame: 10 years
Reproductive outcomes - Menopause Quality of Life (MenQoL) questionnaire
Time frame: 10 years
Psychological outcomes - EORTC-C30 general quality of life questionnaire
Time frame: 10 years
Psychological outcomes - Clinical outcomes in Routine Evaluation (CORE-OM)
Time frame: 10 years
Psychological outcomes - Ten Item Personality Inventory (TIPI)
Time frame: 10 years
Psychological outcomes - Hospital Anxiety and Depression Scale (HADS)
Time frame: 10 years
Psychological outcomes - Distress thermometer
Time frame: 10 years
Psychological outcomes - General Self-Efficacy (GSE) Scale
Time frame: 10 years
Psychological outcomes - Mini-Mental Adjustment to Cancer (Mini-MAC)
Time frame: 10 years
Psychological outcomes - Cancer Worry Scale (CWS)
Time frame: 10 years
Psychological outcomes - Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 10 years
Psychological outcomes - Patient Health Engagement scale
Time frame: 10 years
Psychological outcomes - Supportive Care Needs Survey-Short Form (SCNS-SF34)
Time frame: 10 years
Social outcomes - Medical Consumption Questionnaire (iMCQ)
Time frame: 10 years
Social outcomes - Productivity Cost Questionnaire (iPCQ)
Time frame: 10 years
Social outcomes - Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) tool
Time frame: 10 years
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 19 Sep 2024.
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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.
Giovanni Scambia principal investigator
Fondazione Policlinico Universitario Agostino Gemelli 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 Gynecologic 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 7 inclusion and 2 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: opening soon, 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?
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 Giovanni Scambia (+390630155701, giovanni.scambia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes (time frame: 10 years). 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.