Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Carcinoma

Carcinoma, Renal Cell

Leiomyoma

Myofibroma

Von Hippel-Lindau Disease

Kidney Neoplasms

Disease Susceptibility

Birt-Hogg-Dube Syndrome

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Connective Tissue Diseases

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Neurocutaneous Syndromes

Angiomatosis

Vascular Diseases

Ciliopathies

Congenital Abnormalities

Abnormalities, Multiple

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

BAP1 Tumor Predisposition Syndrome

Hereditary Renal Cell Carcinoma

Hereditary Leiomyomatosis and Renal Cell Cancer

Patients with known or suspected heritable kidney cancer syndromes, including VHL and HLRCC Disease.

Family members (related by blood) of patients who have or are suspected of having heritable kidney cancer syndromes, including VHL and HLRCC Disease.

Patients and biologic family members with a heritable kidney cancer syndrome of suspected, but not proven genetic etiology.

Next generation sequencing of blood, urine and/or benign and malignant tissue of patients and family members with known or suspected heritable kidney cancer syndromes, including VHL and HLRCC Disease.

Gene test

Yunze Xu, Ph.D.

Qi Lu

Jin Zhang

This study will investigate the frequency, clinical phenotype, management and molecular genetic defects of heritable kidney cancer syndromes. Families with kidney cancer with known or suspected genetic basis will be enrolled. Affected individuals or individuals suspected of having a germline kidney cancer will undergo periodic clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. Genetic linkage studies may be performed in situations in which the genetic basis of the disorder has not been elucidated. This research will have a significant impact on the overall management of heritable kidney cancer syndromes patients and family members who are at risk for heritable kidney cancer syndromes. The study will ultimately facilitate the development of novel screening, prevention and treatment strategies for these individuals with the syndrome. In addition this study could have impact on the management of patients with personal and/or family history of heritable kidney cancer syndromes.

Background:

• The genetic etiology of heritable kidney cancer syndromes remains to be determined.

Objectives:

* Define the risk of developing renal cance in heritable kidney cancer syndromes
* Define the types and characteristics (including patterns of growth) of heritable kidney cancer syndromes.
* Determine genotype/phenotype correlations.
* To characterize the natural and clinical histories of heritable kidney cancer syndromes.
* To determine the genetic etiology of heritable kidney cancer syndromes.

Design:

* These rare families will be recruited to genetically confirm diagnosis, determine size and location of renal tumors, size at presentation, growth rate and metastatic potential of renal tumors.
* Genetic testing will be offered to gain appreciation of the effect of mutations on the relative activity of various germline and somatic mutations.
* To determine if there is a relationship between mutation and disease manifestations and phenotype.

Frequency, Clinical Phenotype and Genetic Analysis of Heritable Kidney Cancer Syndromes

Genotyping for genetic variants that could modify the risk of cancer in subjects.

Questionnaire and chart review of the clinical phenotype

Frequency of germline pathogenic/likely pathogenic variants in renal cancer

Ruijin Hospital

Shanghai Zhongshan Hospital

Huashan Hospital

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Zhejiang Provincial People's Hospital

Tongji Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

Shanghai 10th People's Hospital

First Affiliated Hospital, Sun Yat-Sen University

Peking University First Hospital

RenJi Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)

Capmatinib

Sang-We Kim, Prof.

This study is a phase II, single-arm, open label study under an umbrella trial for NSCLC. This clinical study is targeted for the patients who harbor exon 14 skipping mutation of MET and all patients will be treated with Capmatinib. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 28 days.

Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation

An Open-label, Multicenter, Phase II Study of Capmatinib in Patients With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1

DOR is calculated as the time from the date of the first document of complete remission (CR) or partial remission (PR) to the first documented preogressive disease (PD) or death due to any cause for patients with PR or CR.

PFS is defined as time from the first dose of investigational products (IPs) to progression or death due to any cause.

OS is defined as time from the first dose of IPs to death due to any cause.

Asan Medical Center

Professor

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Subjects who, at enrollment, have been on a TKI for less than 4 weeks will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, 1 Week, 2 Weeks, 4 Weeks, 8 Weeks, 16 weeks, and 24 weeks.

Subjects who, at enrollment, have been on a TKI for 4 weeks or more will be monitored with the Sensus smartphone application, Fitbit Sense, RX Cap, and paper surveys. Visits will be at: Screening, Baseline, Week 1, and then every 8 weeks for 24 weeks.

Sensus is capable of administering ecological momentary assessments (EMAs) on a schedule, randomly, or using sensor-triggers. In this way, Sensus will capture both active (patient-initiated) and passive data streams from native smartphone sensors. Passive streams may include, but are not limited to, GPS, accelerometer, gyroscope, and pedometer data. Participants will be able to log data such as their activity, symptoms and medication adherence via user-initiated surveys within the Sensus app. Sensus will also prompt users to record their medication adherence, symptoms, or activity. This will be done either at fixed intervals (e.g., three times daily) or whenever the onboard sensors detect potential changes in a user's physiological state (e.g., shaking / moving around).

Sensus Smartwatch Application

The RXCap medication event monitoring device will be used to collect data on participant adherence to their TKI medication. A small computer chip is included in the top of a pill bottle. When the cap is taken off of the pill bottle by turning it or unscrewing it, the cap records the time and date that it was removed.

RX Cap

The Fitbit Sense smartwatch will be used to collect data including steps, calories burned, total distance travelled, sleep (e.g. time spent sleeping and quality of sleep), flights of stairs climbed, active minutes, exercise (e.g. minutes spent exercising at various intensities), and average heart rate.

Fitbit Sense

Electronic and paper surveys will be administered throughout the study.

Surveys

Ryan Gentzler, MD

In this study, patients who are taking oral tyrosine kinase inhibitor (TKI) therapy for lung cancer will be asked to participate in a remote monitoring system for up to 24 weeks. The system will include:

* a smartphone application (app) developed at the University of Virginia called Sensus. Sensus will be downloaded to the participant's smartphone. The app will collect active data (such as through surveys) and passive data (such as accelerometer data).
* a fitness watch called a Fitbit will be given to the participant to be used during the study. The Fitbit will collect information such as steps and average heart rate.
* a smart pill cap called RX Cap will be given to the participant to be used during the study. The pill cap will collect information about how often a pill bottle is opened.

The study will also involve paper surveys that are taken by the participant during clinic visits. Symptoms related to TKI therapy will be recorded by an investigator in the clinic.

The study results will be used to guide development of a real-time symptom monitoring system, with the ultimate goal of improving TKI symptom response and quality of life.

This is a prospective pilot study for adult patients with lung cancer who have tumors harboring an actionable mutation and who are undergoing treatment with oral tyrosine kinase inhibitors (TKIs). The choice and dose of TKI will be at the discretion of the treating medical oncologist. The study will assess symptoms and adverse events using a remote monitoring system that uses brief self-report surveys and passive input from smart devices as well as clinical assessment of adverse events and quality of life during routine office visits. An application loaded onto a smart phone (Sensus) and a fitness tracking device (Fitbit Sense) will capture information about symptoms and adverse events. This information will be captured through surveys and from passive input from the smart devices. Surveys will also be used to capture the subjects' experience with the devices. The results of this pilot study will be used to guide future development of a mobile health system application for remote real-time symptom monitoring to implement earlier interventions to reduce severity of symptoms, improve quality of life, and avoid drug discontinuations and dose reductions in this patient population.

Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies

Real-Time Monitoring and Modeling of Symptoms and Adverse Events in Lung Cancer Patients Receiving Oral Targeted Therapies for Tumors With Actionable Mutations

Number of participants wearing the device and responding to remote electronic surveys at least 50% of the time.

Adverse event frequency and severity recorded by the app and from in-person clinical assessments using the CTCAE v5.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Frequency, Clinical Phenotype and Genetic Analysis of Heritable Kidney Cancer Syndromes	NCT05534854	Renal Tumor His... Kidney Cancer Renal Cell Carc... Familial Renal ... HLRCC VHL Syndrome BAP1 Tumor Pred... FLCN Gene Mutat... ALK Gene Mutati... FH Gene Mutatio... Birt-Hogg-Dube ... MET Gene Mutati... Cutaneous Leiom... Cutaneous Leiom...	Gene test	2 Years -	RenJi Hospital
Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation	NCT03693339	Cancer Lung Cancer Met... MET Gene Mutati...	Capmatinib	18 Years -	Asan Medical Center
Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation	NCT03693339	Cancer Lung Cancer Met... MET Gene Mutati...	Capmatinib	18 Years -	Asan Medical Center
Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation	NCT03693339	Cancer Lung Cancer Met... MET Gene Mutati...	Capmatinib	18 Years -	Asan Medical Center
Real-Time Monitoring of Symptoms in Lung Cancer Patients Receiving Oral Targeted Therapies	NCT05370469	Lung Cancer EGFR Gene Mutat... EGFR ALK Gene Mutati... RET Gene Mutati... MET Gene Mutati... KRAS Mutation-R... BRAF ROS1 Gene Mutat...	Sensus Smartwat... RX Cap Fitbit Sense Surveys	18 Years -	University of Virginia
Frequency, Clinical Phenotype and Genetic Analysis of Heritable Kidney Cancer Syndromes	NCT05534854	Renal Tumor His... Kidney Cancer Renal Cell Carc... Familial Renal ... HLRCC VHL Syndrome BAP1 Tumor Pred... FLCN Gene Mutat... ALK Gene Mutati... FH Gene Mutatio... Birt-Hogg-Dube ... MET Gene Mutati... Cutaneous Leiom... Cutaneous Leiom...	Gene test	2 Years -	RenJi Hospital

Spots Global Cancer Trial Database for met gene mutation