Symptoms and General Pathology

All Conditions

Recurrence

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Immunomodulating Agents

Momchilo Vuyisich, PhD

Ryan Toma, MS

Jessica Chestnut

Nathalie McKenzie, MD

Robert Holloway, MD

James Kendrick, MD

30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.

30 patients diagnosed with advanced or recurrent gynecological cancer who plan to receive immunotherapy treatment with a checkpoint inhibitor at AHMG AdventHealth Orlando Gynecological Oncology Group are recruited. Patients will be recruited 1-2 weeks prior to the beginning of treatment and appropriate informed consent will be obtained. Fecal samples; blood; saliva and vaginal swab samples will be collected among participants prior to their first treatment, after four doses of immunotherapy, and again at the completion of immunotherapy (follow-up). These 4 biomarker samples will undergo metatranscriptomic analysis, also known as RNAseq, method of sample analysis. Only RNA molecules are sequenced, while DNA is degraded. for bacterial community analysis. These findings will help to design a future study to examine the role of the gut microbiome in antitumor immunity and its effect on immune checkpoint inhibitor therapy for advanced or recurrent gynecological cancer. NHANES Food Frequency Questionnaire will be collected prior to participants' first treatments.

The short-term goals of this pilot study are to obtain preliminary data on the gut bacterial microbiome of patients with advanced or recurrent gynecological cancer. The long-term goals of this study is to begin to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, to gut microbiome differs among patients undergoing immunotherapy, and to examine whether the gut microbiome is associated with the response to cancer immunotherapy.

Only RNA molecules are sequenced, while DNA is degraded. The AdventHealth Research Laboratory will process the de-identified blood samples and store; Plasma, Serum and Buffy Coat for future analysis. The Advent Health Research Laboratory will store these samples in the biorepository, inventory and chain of custody will be managed by the STARLIMS program.

Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy

Changes are measured between the genetic microbiome signatures of advanced or recurrent gynecological cancer patients who are receiving immune checkpoint inhibitors.

AdventHealth

Viome

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Precancerous Conditions

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.

OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.

OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to:

* Dysplasia
* Hyperplasia
* Leukoplakia
* Erythroplasia
* Lichenoid lesions
* Actinic Keratosis
* Lichenoid reaction
* Aphthous ulcer/ Canker Sores
* Gingival enlargement (side effect)
* Lichen planus
* Keratosis
* Inflammatory reaction
* Cheek bites

Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities.

The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome Saliva Collection and Transport Kit, the Viome laboratory process for metatranscriptomics, and the Viome analytical software that detects an RNA expression signature within a saliva sample.

OralViome Cancer Testing System

Mory Mehrtash, MSc

Gavin Hougham, PhD

Bruno Villazhinay, MPH

Cristina Julian, PhD

To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.

This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.

A total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.

Participants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis

The test results will be compared against the definitive diagnosis by the physician.

New York Medical College

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

Have confirmed colorectal cancer-free and Polyp-free colon using colonoscopy

Have benign or precancerous polyps, including tubulovillous or villous adenomas, using colonoscopy

Have confirmed TNM staging of colorectal cancer

The T refers to the size and extent of the main tumor. The main tumor is usually called the primary tumor.

The N refers to the number of nearby lymph nodes that have cancer. The M refers to whether the cancer has metastasized. This means that the cancer has spread from the primary tumor to other parts of the body.

Have confirmed TNM staging of colorectal cancer

This is an observational study with the goal to improve the robustness of the scientific evidence linking Fusobacterium nucleatum (Fn) and/or other microorganisms to colorectal cancer (CRC) onset and/or progression. This is an approximately three-year study. There are two phases to this study, including: 1) pilot phase, 2) full study. There are also five arms in this study including cancer-free, pre-cancerous, and Colorectal cancer stages (I-III). The pilot study will include the recruitment of 50 participants per group (i.e., total of 250 participants). The full study will have an additional 150 participants per group (total of 1,000 participants). This study will recruit using clinical sites in the United States.

There are 5 timepoints in this study. If the participants are found to be medically eligible through diagnosis and medical information, they will provide samples (including: saliva, blood, urine, stool and tumor biopsy) at each timepoint and during the study. They will also answer health and wellness questions during this study. Additional data collection, including medical data, biopsies and other biological samples might happen at interim timepoints in case of adenoma/cancer disease progression (recurrence, metastasis). The participant's healthcare provider will determine if additional biopsies are required as a part of the standard of care. If collected, additional samples will be sent for research purposes.

This is an exploratory, longitudinal study that will follow approximately 1,000 participants over 4-6 clinical sites nationwide over a period of 3-4 years and collect molecular and phenotype data to obtain insights into the microbiome and colorectal cancer. Each site will enroll approximately 166-250 participants in total. Those that are polyp/cancer free, pre-cancerous and confirmed primary diagnosis of colorectal cancer (stage I, II and III) will be recruited. Participants will be recruited in primary, secondary, and tertiary care centers, depending on the study inclusion/exclusion criteria.

Participants complete surveys and collect samples including (blood, urine, stool, and saliva) using at-home/in-clinic kits provided by Viome. Participants are also asked to provide tissue or tumor samples if collected by their healthcare provider during a standard of care biopsy procedure. Biopsy samples for this test will be collected by the clinical staff at each study site. Additional data collection, including medical data, biopsies and other biological samples might happen at interim timepoints in case of adenoma/cancer disease progression (recurrence, metastasis). Additionally, participants complete a survey sent on a quarterly basis.

There are 5 timepoints (TP) in this study including: Timepoint 1, Timepoint 2, Timepoint 3, Timepoint 4, and Timepoint 5.

TP1 includes the initial diagnosis where the stage of cancer is determined by imaging (colorectal cancer stages I, II, or III) or colonoscopy results (healthy and pre-cancerous). All participants provide urine, blood, saliva, stool and complete survey.

TP2 includes Post Standard of Care (SOC). For cancer participants, samples will be collected 45 +/- 15 days after all treatments have been completed (this includes chemotherapy, radiation therapy, immunotherapy, and/or surgery). Those that are healthy and pre-cancerous will provide their samples, 90 +/- 15 days after the colonoscopy. All participants provide urine, blood, saliva, stool and complete survey.

TP3, 4, and 5 occur 1, 2 and 3 years respectively after diagnosis (TP1) for cancer-free and precancerous groups and 1, 2 and 3 years respectively after standard of care therapy (TP2) for the cancer groups. All participants provide urine, blood, saliva, stool and complete survey.

Microbiome in Colorectal Cancer Onset and Progression

The Role of the Microbiome in Colorectal Cancer Onset and Progression

Determine Fn species and strains, more specifically the prevalence and relative activity, and the differential gene expression and key pathways. The Investigators will also look at Microbial co-occurrence/abundance with Fn and local tumor microenvironment and tumor marker/mutations and their association with microbiome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy	NCT04957511	Gynecologic Can... Immunotherapy Gut Microbiome		18 Years -	Viome
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System	NCT05451303	Oral Squamous C... Oropharynx Squa... Premalignant Le...	OralViome Cance...	18 Years -	Viome
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System	NCT05451303	Oral Squamous C... Oropharynx Squa... Premalignant Le...	OralViome Cance...	18 Years -	Viome
Microbiome in Colorectal Cancer Onset and Progression	NCT05368688	Colorectal Canc... Tumor CRC GI Cancer Gastrointestina...		50 Years - 80 Years	Viome

Spots Global Cancer Trial Database for viome

Every month we try and update this database with for viome cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for viome

Every month we try and update this database with for viome cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for viome cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.