- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05496517
Ovarian Cancer Individualized Scoring System Scoring System (OCISS)
Ovarian Cancer Individualized Scoring System (OCISS) for Prediction of Ovarian Cancer Prognosis
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Ovarian cancer (OC) is one of the most common types of malignant tumors and the eighth cause of cancer-related mortality in women.[1] Among gynecological cancers, it is ranked the third following cervical and uterine cancers and is associated with the worst prognosis
[1]. Globally, there are 313,959 new cases and 207,252 deaths of OC annually [1].
Compared to breast cancer, OC is approximately three times more lethal [2]. The high mortality rate of OC is attributed to the capacious anatomical space through which the tumor can grow before it causes significant symptoms, growth of the tumor within abdominal cavity rendering spread of malignant cells widespread and prompt, direct lymphatic drainage to aortic lymph nodes, lack of specific diagnostic symptoms, and unavailability of an efficient screening strategy [3,4]. Symptoms of OC are nonspecific and include vague abdominal pain, abdominal bloating, urinary frequency, early satiety, feeling full, or changes in bowel habits, most of which mimic common gastrointestinal symptoms [5]. Risk factors of OC include obesity, old age, smoking, genetic predisposition, and endometriosis [6,7]. FIGO staging is considered the standard classification system that determines prognosis and management of newly diagnosed OC. However, there are numerous gaps in this staging system that would limit interpretation of clinically relevant data [8]. For instance, the staging system does not consider crucial disease prognostic factors, such as histological type and grade, which are usually considered separately based on available evidence and internal policies. This multi-layer guidance adds to the complexity of decision making. Similarly, personalized management is overlooked since these staging systems do not appreciate individual characteristics such as age, menopausal states, comorbidities, and genetic predisposition. All patients with positive lymph nodes are grouped into a single stage in FIGO staging system, which creates a very diverse group of patients with highly variable survival rates [9]. Management of ovarian cancer is surgical and comprises bilateral sapling-oophorectomy, total abdominal hysterectomy , and infracolic omentectomy. Additional surgical steps and neoadjuvant therapy are potentially determined by disease characteristics. Extent of surgery and neoadjuvant treatment is directly related to postoperative comorbidities and contributes to long term prognosis.
[10]. Therefore, development of an individualized prognostic and decision-making system, based on large multicenter studies, would facilitate accurate prediction of disease prognosis and determination of individualized management strategy.
The study will comprise at least 8 international cancer centers. Data of patients, newly diagnosed with OC between January 2010 and December 2016, will be retrospectively collected. Therefore, a follow-up of at least 5 years would be granted. All women who will be diagnosed with primary ovarian cancer at any stage, of all histological types and grades eligible for the study. All contributing centers should acquire institutional review board (IRB) approval prior to data collection.
Inclusion criteria:
- Women diagnosed with ovarian cancer between January 2010 and December 2016.
- Primary non-recurrent diagnosis of ovarian cancer.
- Women should be diagnosed and managed by the corresponding center.
- Patients with adequate clinical and pathological data
Exclusion criteria:
- Inadequate information and follow-up for at least 5 years.
- Authorization to use anonymous patient data for research purposes. Data will be collected using an excel spreadsheet designed for this study and shared among contributing centers. Data include patients' demographics such as age, parity, body mass index, ethnicity, smoking index, contraception method, menopausal status, medical comorbidities [coronary artery disease, diabetes on insulin, hypertension, chronic renal 3 disease, chronic lung disease, thyroid dysfunction], preoperative imaging [cancer stage, involvement of ovaries, surface involvement, uterine involvement, tubal involvement, inguinal lymph nodes (number, largest diameter), extra abdominal lymph nodes (size and enlargement), abdominal invasion (omental deposits > 2cm, peritoneal carcinomatosis), other pelvic invasion], positive cytology, grade (high/low), pleural effusion and cytology, ascites, performance status, histological type, biomarkers, BRCA I and II (germline or somatic), and serum albumin level. Details of management plan will be collected including treatment approach [Time from diagnosis to surgery, Surgical approach, PA lymphadenectomy (systematic, selective, none)], chemotherapy [systematic or intraperitoneal], and other treatments given.
Treatment outcomes such as complications, debulking success, spill, nodal metastasis, microscopic peritoneal metastasis, microscopic omental metastasis, response to chemotherapy, and CA 125 changes will be included. Data will not include any identifiable information.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Sherif Shazly
- Numero di telefono: +4407554480388
- Email: sherif.shazly.mogge@gmail.com
Luoghi di studio
-
-
-
Alexandria, Egitto, 21516
- Alexandria University Main Hospital
-
Contatto:
- Ahmed H. Ismail
- Numero di telefono: 01144557597
- Email: ahmed.ismail.mogge@gmail.com
-
Assiut, Egitto, 71511
- Assiut Hospitals university
-
Contatto:
- Manar M. Ahmed
- Numero di telefono: 01128793950
- Email: manar.mahran.mogge@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
Women diagnosed with ovarian cancer between January 2010 and December 2016.
- Primary non-recurrent diagnosis of ovarian cancer.
- Women should be diagnosed and managed by the corresponding center.
- Patients with adequate clinical and pathological data
Exclusion Criteria:
• Inadequate information and follow-up for at least 5 years.
- Authorization to use anonymous patient data for research purposes.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Retrospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Cancer-specific survival (CSS) rate at 5 years
Lasso di tempo: Within 5 years after diagnosis of ovarian cancer
|
Percentage of women newly diagnosed with ovarian cancer who do not die from ovarian cancer after 5 years
|
Within 5 years after diagnosis of ovarian cancer
|
Cancer-specific survival (CSS) rate at 3 years
Lasso di tempo: Within 3 years after diagnosis of ovarian cancer
|
Percentage of women newly diagnosed with ovarian cancer who do not die from ovarian cancer after 3 years
|
Within 3 years after diagnosis of ovarian cancer
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Recurrence-free survival (RFS) rate at 5 years
Lasso di tempo: Within 5 years of diagnosis of ovarian cancer
|
Percentage of newly diagnosed women who do not experience disease recurrence during follow-up
|
Within 5 years of diagnosis of ovarian cancer
|
Recurrence-free survival (RFS) rate at 3 years
Lasso di tempo: Within 3 years of diagnosis of ovarian cancer
|
Percentage of newly diagnosed women who do not experience disease recurrence during follow-up
|
Within 3 years of diagnosis of ovarian cancer
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Caan BJ, Thomson CA. Breast and ovarian cancer. Optim Women's Heal through Nutr. Published online 2007:229-263. doi:10.1369/0022155411428469
- Urban N. Early detection of ovarian cancer: Methodological considerations. Int J Gynecol Obstet. 2000;70:D9-D9. doi:10.1016/s0020-7292(00)82512-6
- Jacobs IJ, Menon U. Progress and challenges in screening for early detection of ovarian cancer. Mol Cell Proteomics. 2004 Apr;3(4):355-66. Epub 2004 Feb 5. Review.
- Goff BA, Mandel LS, Melancon CH, Muntz HG. Frequency of symptoms of ovarian cancer in women presenting to primary care clinics. JAMA. 2004 Jun 9;291(22):2705-12. doi: 10.1001/jama.291.22.2705.
- Jordan SJ, Green AC, Whiteman DC, Webb PM; Australian Ovarian Cancer Study Group. Risk factors for benign, borderline and invasive mucinous ovarian tumors: epidemiological evidence of a neoplastic continuum? Gynecol Oncol. 2007 Nov;107(2):223-30. Epub 2007 Jul 27.
- Momenimovahed Z, Tiznobaik A, Taheri S, Salehiniya H. Ovarian cancer in the world: epidemiology and risk factors. Int J Womens Health. 2019 Apr 30;11:287-299. doi: 10.2147/IJWH.S197604. eCollection 2019.
- Salvo G, Odetto D, Pareja R, Frumovitz M, Ramirez PT. Revised 2018 International Federation of Gynecology and Obstetrics (FIGO) cervical cancer staging: A review of gaps and questions that remain. Int J Gynecol Cancer. 2020 Jun;30(6):873-878. doi: 10.1136/ijgc-2020-001257. Epub 2020 Apr 1. Review.
- Wright JD, Matsuo K, Huang Y, Tergas AI, Hou JY, Khoury-Collado F, St Clair CM, Ananth CV, Neugut AI, Hershman DL. Prognostic Performance of the 2018 International Federation of Gynecology and Obstetrics Cervical Cancer Staging Guidelines. Obstet Gynecol. 2019 Jul;134(1):49-57. doi: 10.1097/AOG.0000000000003311.
- McCorkle R, Pasacreta J, Tang ST. The silent killer: psychological issues in ovarian cancer. Holist Nurs Pract. 2003 Nov-Dec;17(6):300-8. Review.
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urogenitali
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie genitali, femmina
- Malattie del sistema endocrino
- Malattie ovariche
- Malattie annessiali
- Disturbi gonadici
- Neoplasie delle ghiandole endocrine
- Neoplasie ovariche
- Carcinoma, epiteliale ovarico
Altri numeri di identificazione dello studio
- MOGGE-GO03
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro ovarico
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsAttivo, non reclutanteEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaTaiwan, Stati Uniti, Olanda, Spagna, Corea, Repubblica di, Italia, Giappone, Canada, Singapore
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
-
University of ChicagoNational Cancer Institute (NCI)CompletatoAdenocarcinoma pancreatico | Adenocarcinoma gastrico | Adenocarcinoma pancreatico metastatico | Neoplasia gastrointestinale maligna | Cancro al pancreas in stadio III | Cancro al pancreas in stadio IV | Carcinoma della cistifellea | Cancro alla cistifellea in stadio IV | Cancro gastrico in stadio IV | Cancro... e altre condizioniStati Uniti