Urine Omics Predicting IO Therapy Responses in mUC Patients | NCT04641936

Studies
Urine Omics Predicting IO Therapy Responses in mUC Patients

NCT04641936

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Apr 17, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Metastatic Urothelial Carcinoma

Interventions

No intervention required

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2020Actual

Primary Completion Date

Oct 31, 2025Estimated

Completion Date

Oct 31, 2027Estimated

First Submitted Date

Nov 18, 2020

First Submission Date that Met QC Criteria

Nov 18, 2020

First Posted Date

Nov 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic urothelial carcinoma.

Detailed Description

This is a multi-center single-arm translational study where patients with mUC who are about to receive pre-determined IO-based anti-tumor therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A		Training cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers.	Other: No intervention required
Cohort B		Validation cohort will be recruited in the next 36 months of the study period.	Other: No intervention required

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention required	Other	No intervention required	Cohort A Cohort B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)		7 years
Progression-free survival (PFS)		7 years
Duration of response (DOR)		7 years
Overall survival (OS)		7 years
Adverse event of special interest (AESI)		7 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Age > 20 years
2. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
3. Subjects who are about to receive IO-based therapy
4. ECOG performance 0, 1, 2, and 3
5. Life expectancy 3 months
6. eGFR > 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
7. Willing to sign the informed consent form

Exclusion Criteria:

1. Subjects NOT willing to sign the informed consent form
2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF
3. Subjects having co-existing other malignancies that need active treatment. Those with other malignancies that do not need active treatment are allowed to join the study.
4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
5. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
6. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for >12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy are allowed to join the study.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Advanced and metastatic UC patients who will receive IO-based therapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeong Shiau Pu, MD PhD	Contact	886-2-23123456	65254	pu5249@ntuh.gov.tw
Chung Hsin Chen, MD PhD	Contact	886-2-23123456	65242	mufasachen@gmail.com

Overall Officials

Name	Affiliation	Role
Yeong Shiau Pu, MD PhD	Department of Urology, National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms