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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA261605 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
HNSCCis a lethal cancer with a 5-year survival rate below 50%. Although smoking, alcohol intake, and human papillomavirus (HPV) infection are linked to HNSCC, only a small proportion of individuals exposed to these factors develop cancer and not all cases progress. Thus, additional environmental or host factors must contribute to HNSCC. The Study Team and others have observed significant oral dysbiosis in human HNSCC cases, both before and after treatment. This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Squamous Cell Carcinoma Saliva Sample Group | Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at -80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms. |
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| Non Oral Squamous Cell Carcinoma Saliva Sample Group | Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at -80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms. |
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| Oral Squamous Cell Carcinoma Stool Sample Group | Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.). |
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| Non Oral Squamous Cell Carcinoma Stool Sample Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metagenomic sequencing | Diagnostic Test | Shotgun metagenomic sequencing will characterize cancer-associated changes in microbial functional capacity and species/strain-level taxonomic profiles. Metagenomics will provide data on microbial functional capacity along with broader taxonomic classifications. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize human dysbiosis | Stool and saliva samples will be collected from participants, allowing us to reproduce human dysbiosis and analyze whether HNSCC affects one's microbiome composition. Metagenomic sequencing will be conducted through use of DNA extraction, library generation and Illumina sequencing. At least 30 million paired-end 2x150bp metagenomic reads will be generated per sample using the Illumina NovaSeq platform. | Day 1 |
| Characterize human metabolomics | Through our stool and saliva samples we will be able to characterize metagenomic and metabolic signatures in treatment naïve OSCC and non-OSCC patients. Metabolic analysis will be conducted using LC/MS-based metabolic analysis. A targeted approach will quantify a panel of 30 componds including Trp pathway products, while a non-targeted approach, when applied to both lipid and aqueous phase compounds, will profile relative changes in compounds that may influence host and metabolic and immune statuses. | Day 1 |
| Integrative multi-omic data analysis and biomarker discovery | We expect to find that specific sets of microbial and host factors interact with each other to promote OSCC. | Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of human dysbiosis on OSCC development in mice | Freshly collected saliva and stool samples from 10 subjects of each treatment category will be used to reconstitute microbiota. | Day 10-Day 100 |
| Monitor tumor size |
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Inclusion Criteria:
Exclusion Criteria:
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We aim to enroll 60 patients total - 30 with oral squamous cell carcinoma (OSCC) who are treatment naïve, and 30 who are non-OSCC control patients, who will be age matched to their OSCC counterparts. Estimates show that Dr. Goddard's practice sees approximately 3 treatment naïve OSCC cases per month. We estimate that we can enroll 30-40 of these cases and an equal number of controls in the first 18 months of this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yosr Doghri | Contact | (303) 724-6550 | yosr.doghri@cuanschutz.edu | |
| Kristi Engle Folchert | Contact | (303) 724-9528 | kristi.englefolchert@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shi-Long E Lu, MD, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008048 | Lip Neoplasms |
| D009062 | Mouth Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D064688 | Metabolic Flux Analysis |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).
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| Metabolic analysis | Diagnostic Test | Metabolic analysis will be conducted using LC/MS-based metabolic analysis. A targeted approach will quantify a panel of 30 compounds including Trp pathway products while a non-targeted approach, when applied to both lipid and aqueous phase compounds, will profile relative changes in compounds that may influence host |
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Tumor size (both weight and size) will be monitored using Bli-imaging. These measures will be assessed between treatment groups by ANOVA or analysis of variance testing.
| Day 10-Day 100 |
| D009057 |
| Stomatognathic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D008919 | Investigative Techniques |