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出境医 / 临床实验 / Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America

Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America

Study Description
Brief Summary:
The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.

Condition or disease
Recurrent/Metastatic Urothelial Cancers

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : May 2, 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Epidemiology [ Time Frame: 2 years ]
    Overall survival (OS) will be defined from the date of treatment initiation to date of death from any cause. In case of patients that received palliative care only, OS will be defined from date of diagnosis of advanced disease to date of death from any cause. Patients who are alive will be censored at the date of last known contact.


Secondary Outcome Measures :
  1. Socioeconomic chactacteristcs [ Time Frame: 2 years ]
    Health Care Insurance (Public or Private)

  2. Overall response [ Time Frame: 2 years ]
    Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1

  3. Duration of response [ Time Frame: 2 years ]
    Defined as the time from response to progression by RECIST v11.1 or death

  4. PFS [ Time Frame: 2 years ]
    Progression-free survival (PFS) will be defined from date of treatment initiation to date of disease progression or death from any cause, whichever occurs first in each line.


Biospecimen Description:
Archived tumor samples from Formalin-Fixed Paraffin-Embedded (FFPE) blocks or slides.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.
Criteria

Inclusion Criteria:

  1. Age at least 18 years;
  2. Histological confirmation of urothelial carcinoma (include mixed urothelial histology);
  3. Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018;
  4. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records;
  5. Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration.

Exclusion Criteria:

  1. Synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers);
  2. Pure non-urothelial carcinoma histology.
Contacts and Locations

Contacts
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Contact: Laura Voelcker +55 51 3384 5334 laura.voelcker@lacogcancerresearch.org

Locations
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Brazil
CLION Recruiting
Salvador, BA, Brazil
Contact: Fernando de Oliveira         
Clínica AMO Recruiting
Salvador, BA, Brazil
Contact: Vinícius Carrera Souza         
Hospital São Rafael Recruiting
Salvador, BA, Brazil
Contact: Breno Pereira e Silva         
LIGA Recruiting
Curitiba, PR, Brazil
Contact: Murilo de Almeida Luz         
CPO Pucrs Recruiting
Porto Alegre, RS, Brazil
Contact: André Fay         
CEPON Recruiting
Florianópolis, SC, Brazil
Contact: Marcelo Freitas         
Beneficência Portuguesa Recruiting
São Paulo, SP, Brazil
Contact: Fernando Maluf         
Centro Paulista de Oncologia Recruiting
São Paulo, SP, Brazil
Contact: Andrey Soares         
Sírio Libanês Recruiting
São Paulo, SP, Brazil
Contact: Diogo Bastos         
Sponsors and Collaborators
Latin American Cooperative Oncology Group
Janssen-Cilag Ltd.
Investigators
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Study Director: Gustavo Werutsky, MD Latin American Cooperative Oncology Group
Tracking Information
First Submitted Date April 25, 2019
First Posted Date May 8, 2019
Last Update Posted Date December 29, 2020
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2019) 		Epidemiology [ Time Frame: 2 years ]
Overall survival (OS) will be defined from the date of treatment initiation to date of death from any cause. In case of patients that received palliative care only, OS will be defined from date of diagnosis of advanced disease to date of death from any cause. Patients who are alive will be censored at the date of last known contact.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2019)
  • Socioeconomic chactacteristcs [ Time Frame: 2 years ]
    Health Care Insurance (Public or Private)
  • Overall response [ Time Frame: 2 years ]
    Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1
  • Duration of response [ Time Frame: 2 years ]
    Defined as the time from response to progression by RECIST v11.1 or death
  • PFS [ Time Frame: 2 years ]
    Progression-free survival (PFS) will be defined from date of treatment initiation to date of disease progression or death from any cause, whichever occurs first in each line.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America
Official Title Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database
Brief Summary The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Archived tumor samples from Formalin-Fixed Paraffin-Embedded (FFPE) blocks or slides.
Sampling Method Non-Probability Sample
Study Population Patients with recurrent/ metastatic urothelial carcinoma diagnosed between January 2016 to July 2018.
Condition Recurrent/Metastatic Urothelial Cancers
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 1. Milowsky MI, Rumble RB, Booth CM, et al. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016;34(16):1945-1952. doi:10.1200/JCO.2015.65.9797 2. Instituto Nacional de Câncer José Alencar Gomes. Estimativa 2018: Incidência de Câncer No Brasil. Rio de Janeiro: INCA; 2018. http://www.inca.gov.br/estimativa/2018. 3. International Agency for Research on Cancer, International Association of Cancer Registries. Cancer Incidence in Five Continents. Volume X Volume X.; 2014. http://www.iarc.fr/en/publications/pdfs-online/epi/sp164/. Accessed November 21, 2018. 4. Secretaria de Estado da Saúde de São Paulo. FOSP - Fundação Oncocentro de São Paulo. http://www.fosp.saude.sp.gov.br/. Accessed October 30, 2018. 5. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-1259. doi:10.1016/S0140-6736(00)02799-9

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 6, 2019) 		204
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2, 2023
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age at least 18 years;
  2. Histological confirmation of urothelial carcinoma (include mixed urothelial histology);
  3. Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018;
  4. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records;
  5. Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration.

Exclusion Criteria:

  1. Synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers);
  2. Pure non-urothelial carcinoma histology.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Laura Voelcker +55 51 3384 5334 laura.voelcker@lacogcancerresearch.org
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03942497
Other Study ID Numbers LACOG 1518
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Latin American Cooperative Oncology Group
Study Sponsor Latin American Cooperative Oncology Group
Collaborators Janssen-Cilag Ltd.
Investigators
Study Director: Gustavo Werutsky, MD Latin American Cooperative Oncology Group
PRS Account Latin American Cooperative Oncology Group
Verification Date December 2020

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