Multicenter Database of Patients With Germ Cell Tumor
23. december 2021 opdateret af: Latin American Cooperative Oncology Group
Multicenter Database of Patients With Germ Cell Tumor in Order to Characterize Clinicopathologically and to Evaluate Cancer Treatment Outcomes
Retrospective and prospective cohort of patients with germ cell tumor in treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The primary objective of this study is to create a multicenter database in order to characterize epidemiologically and clinicopathologically patients with germ cell tumor and evaluate the prognosis and clinical outcomes during cancer treatment.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1315
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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São Paulo, Brasilien
- Hospital Israelita Albert Einstein
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São Paulo, Brasilien
- ICESP
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São Paulo, Brasilien
- Hospital São José
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien
- CPO - Pucrs
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Men with diagnosis of testicular, retroperitonium or mediastinal primary tumor.
Beskrivelse
Inclusion Criteria:
- Male patients with diagnosis of testicular, retroperitoneum or mediastinal primary tumor.
- Histological confirmation of germ cell tumor or clinical condition based on the elevation of tumor markers (AFP, HCG e/ou DHL) associated to testicular mass or/and retroperitoneal lymphnode enlargement or/and mediastinal mass.
- Medical records of the disease and treatment
Exclusion Criteria:
- Female patients diagnosed with ovary germ cell tumor
- Male patients diagnosed with germ cell tumor in other locations.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Brazilian multicenter database in order to collect and analyze data from diagnosis and treatment of patients with germ cell tumor
Tidsramme: From 2000 to 2025
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From 2000 to 2025
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Description of demographic characteristics of testicular germ cell tumor patients in Brazil
Tidsramme: From 2000 to 2025
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From 2000 to 2025
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The clinical and pathological characteristics of testicular germ cell tumor patients in Brazil.
Tidsramme: From 2000 to 2025
|
From 2000 to 2025
|
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Treatment according to staging and relapse of patients diagnosed with testicular germ cell tumor in Brazil
Tidsramme: From 2000 to 2025
|
From 2000 to 2025
|
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Disease free survival of patients diagnosed with germ cell tumor stage 1.
Tidsramme: From 2000 to 2025
|
From 2000 to 2025
|
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Overall survival of patients diagnosed with germ cell tumor stage 1.
Tidsramme: From 2000 to 2025
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From 2000 to 2025
|
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Disease free survival of patients diagnosed with germ cell tumor stages 2 and 3.
Tidsramme: From 2000 to 2025
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From 2000 to 2025
|
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Overall survival of patients diagnosed with germ cell tumor stages 2 and 3.
Tidsramme: From 2000 to 2025
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From 2000 to 2025
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International prognostic factors in patients with advanced germ cell tumor (stages 2 and 3) stablished by the International Germ Cell Cancer Collaborative Group in brazilian patients.
Tidsramme: From 2000 to 2025
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From 2000 to 2025
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Treatment outcome in different populations: in patients with brain metastasis, patients with germinative tumor extragonodal, surgery outcome in patients with nonseminomous tumor and ressection of residual lesion after chemotherapy
Tidsramme: From 2000 to 2025
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From 2000 to 2025
|
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Disease free survival of patients diagnosed with disease relapse after first line chemotherapy
Tidsramme: From 2000 to 2025
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From 2000 to 2025
|
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Overall survival of patients diagnosed with disease relapse after first line chemotherapy
Tidsramme: From 2000 to 2025
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From 2000 to 2025
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Prognostic model after first line treatment failure with cisplatin, stablished by the International Prognostic Factors Study Group in brazilian patients.
Tidsramme: From 2000 to 2025
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From 2000 to 2025
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group
- Ledende efterforsker: Diogo Bastos, MD, Instituto do Cancer do Estado de Sao Paulo
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2016
Primær færdiggørelse (Faktiske)
1. december 2019
Studieafslutning (Faktiske)
1. december 2020
Datoer for studieregistrering
Først indsendt
7. juli 2016
Først indsendt, der opfyldte QC-kriterier
8. august 2016
Først opslået (Skøn)
11. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. december 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LACOG 0515
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .