## Protocol Section
### Identification Module
**NCT ID:** NCT03699579

**Brief Title:** Pharmaco-Economic Study of Treatment Options in Patients With Advanced RCC

**Official Title:** Patients Characteristics, Treatment Utilization, Costs and Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) Who Received at Least One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy in Taiwan

#### Organization Study ID Info
**ID:** A-TW-60000-022
#### Organization
**Class:** INDUSTRY
**Full Name:** Ipsen
### Status Module
#### Completion Date
**Date:** 2019-06-23

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-08-28

**Type:** ACTUAL

**Last Update Submit Date:** 2019-08-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-06-23

**Type:** ACTUAL

#### Start Date
**Date:** 2019-02-22

**Type:** ACTUAL

**Status Verified Date:** 2019-08

#### Study First Post Date
**Date:** 2018-10-09
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-05
**Study First Submit QC Date:** 2018-10-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Ipsen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.

### Conditions Module

**Conditions:**

- Renal Cell Carcinoma Metastatic

- Renal Cell Carcinoma

**Keywords:**

- advanced or metastatic renal cell carcinoma (RCC)

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Medication usage

**Time Frame:** From start point for 2.5 months

**Measure:** Treatment's duration

**Time Frame:** From start point for 2.5 months

#### Secondary Outcomes

**Measure:** Cost of medication used

**Time Frame:** From start point for 2.5 months

**Description:** (total calculated costs attributed to Adverse Effects (AEs) management according to the attached list of adverse events

**Measure:** Costs of adverse event management

**Time Frame:** From start point for 2.5 months

**Description:** Outpatient department visits, CT scan, blood test number and types

**Measure:** Frequency of health resource usage

**Time Frame:** From start point for 2.5 months

**Description:** Outpatient department visits, CT scan, blood test number and types

**Measure:** Cost of health resource usage

**Time Frame:** From start point for 2.5 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with confirmed diagnosis of clear-cell renal cell carcinoma
* Patients with evidence of metastatic disease
* Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib
* Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease

Exclusion Criteria:

* Patients enrolled in any clinical trial involving anti-cancer therapy
* Pregnant woman

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Hospital chart review study

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taipei

**Country:** Taiwan

**Facility:** National Taiwan University Hospital

**Zip:** 100

**Location 2:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Taipei Veterans General Hospital

**Zip:** 112

#### Overall Officials

**Official 1:**

**Affiliation:** Ipsen

**Name:** Ipsen Medical Director

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000007680

- Term: Kidney Neoplasms

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5548

- Name: Carcinoma, Renal Cell

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4906

- Name: Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

- ID: T1341

- Name: Clear Cell Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002292

- Term: Carcinoma, Renal Cell

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M18681

- Name: Endothelial Growth Factors

- Relevance: LOW

- As Found: Unknown

- ID: M11900

- Name: Mitogens

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
