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PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748901
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

Brief Summary:

This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1 expression status in patients with RCC who have received systemic chemotherapy for recurrent or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in PD-L1-negative RCC.

Total 600 RCC surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at about 30 participating study sites in Japan.

PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3 (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed between IC0 and IC1/2/3.


Condition or disease
Renal Cell Carcinoma

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Multicenter Analysis of PD-L1 Expression in Japanese Renal Cell Carcinoma Patients
Actual Study Start Date : December 16, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort
Full analysis set
Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression



Primary Outcome Measures :
  1. Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients. [ Time Frame: Baseline ]
    Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.


Secondary Outcome Measures :
  1. Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3) [ Time Frame: Baseline ]
    Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.

  2. Overall survival after nephrectomy (including cytoreductive nephrectomy) [ Time Frame: Baseline ]
    Overall survival is defined the time from nephrectomy (including cytoreductive nephrectomy) to death due to any cause.

  3. Time to recurrence after radical nephrectomy [ Time Frame: Baseline ]
    Time to recurrence after radical nephrectomy is the duration from the day of surgery to diagnosis of recurrent.

  4. Treatment duration (first-line and second-line therapy) [ Time Frame: Baseline ]
    Treatment duration is the duration from the day1 of systemic therapy for mRCC to the end of the treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression
Criteria

Inclusion Criteria:

  • 1. Written informed consent for this study. In the case obtaining written informed consent is difficult due to death, change of address, and so on, the opt-out consent is accepted by giving patients or their relatives notification regarding the usage of their clinical information and surgical samples for the research.
  • 2. Age at nephrectomy≧20 years
  • 3.Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression

Exclusion Criteria:

  • 1. Malignancies other than RCC is co-existed from the time of nephrectomy and death.
  • 2. Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line therapy for recurrent or metastatic RCC.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748901


Locations
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Japan
Aichi Medical University
Nagoya-city, Aichi, Japan, 480-1103
Sponsors and Collaborators
Chugai Pharmaceutical
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Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT03748901    
Other Study ID Numbers: CMA-Ate004
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (ClinicalStudyDataRequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases