How Microbes and Metabolism May Predict Skin Cancer Immun... | NCT03370861

Studies
How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes

NCT03370861

Sponsor

Washington University School of Medicine

Status

Terminated

Last Update Posted

Sep 5, 2024Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Autoimmunity
Melanoma
Merkel Cell Carcinoma
Squamous Cell Carcinoma of the Skin
Basal Cell Carcinoma
Skin Cancer

Interventions

Immunotherapy

Countries

United States

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Subject recruitment was limited severely by the 2020-2023 COVID-19 pandemic, which led this study to be closed.

Expanded Access Info

Start Date

Nov 8, 2017Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Dec 7, 2017

First Submission Date that Met QC Criteria

Dec 11, 2017

First Posted Date

Dec 12, 2017Actual

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

Aug 31, 2024

Last Update Posted Date

Sep 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

William H. McCoy IV, MD, PhD, Research Instructor of Medicine, Washington University School of MedicinePrincipal Investigator

Lead Sponsor

Washington University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.

Detailed Description

Details will be available upon publication.

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

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunotherapy	Biological	Medications that increase the activity of the immune system.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune-related Adverse Events (irAEs)	Electronic medical records will be queried for specific drug-related adverse events known as immune-related Adverse Events (irAEs) including but not limited to colitis, hypophysitis, hepatitis, pneumonitis, pancreatitis, arthritis, rash, and vitiligo.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall Survival	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18 years of age.
Diagnosis of skin cancer.
Planning to initiate or already on ANY type of immunotherapy.
Able to provide urine and stool specimens.

Exclusion Criteria:

Bowel resection.
Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with skin cancer planning to initiate or already on ANY type of immunotherapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William H McCoy IV, MD, PhD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barnes-Jewish Hosptial		St Louis	Missouri	63110	United States

Condition Browse Module

MeSH Terms

ID	Term
D001327	Autoimmune Diseases
D008545	Melanoma
D015266	Carcinoma, Merkel Cell
D002280	Carcinoma, Basal Cell
D012878	Skin Neoplasms

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007167	Immunotherapy

Ancestor Terms

ID	Term
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided