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On-Study - Palliative Treatment for Head and Neck Cancer - On-Study Form - 2267713v3.0 - Palliative Treatment for Head and Neck Cancer - On-Study Form

- 9/20/21 - 1 form, 9 itemgroups, 85 items, 1 language

Itemgroups: CRF Header, Head & Neck: Form Administration, Head & Neck: Patient Assessment, Head & Neck: Disease Description - Initial Diagnosis of Disease, Head & Neck: Disease Description - Current Diagnosis, Head & Neck: Prior Health History - Palliative, Head & Neck: Prior Treatment - Systemic Therapy, Head & Neck: Prior Treatment - Radiation Therapy, Head & Neck: Prior Treatment - Surgery

Palliative Treatment for Head and Neck Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=20B9E4F5-9DD3-2343-E044-0003BA3F9857

NCT01302834 Quality of Life - RTOG 1016 QN: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Hearing Handicap Inventory for Adults (HHIA-S) - 3183758v1.0 - RTOG 1016 QN: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Hearing Handicap Inventory for Adults (HHIA-S)

- 1/9/15 - 1 form, 2 itemgroups, 18 items, 1 language

Itemgroups: Header Module, HEARING HANDICAP INVENTORY FOR ADULTS SCREENING QUESTIONNAIRE (NEWMAENT AL., 1990; NEWMAENT AL., 1991)

RTOG 1016 QN: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Hearing Handicap Inventory for Adults (HHIA-S) Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A132BA5-9085-FFE2-E040-BB89AD43727A

Eligibility Head and Neck Cancer NCT02442739

- 4/2/19 - 1 form, 2 itemgroups, 22 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Safety Study of Ketamine for Preventing Depression in Patients Undergoing Treatment for Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02442739

dbGaP phs001179 Foundation Medicine Adult Cancer Clinical Dataset (FM-AD) - Eligibility

- 5/29/23 - 3 forms, 1 itemgroup, 1 item, 1 language

Itemgroup: IG.elig

Principal Investigator: Doron Lipson, PhD, Foundation Medicine Inc., Cambridge, MA, USA MeSH: Neoplasms,Thoracic Neoplasms,Digestive System Neoplasms,Breast Neoplasms,Urogenital Neoplasms,Endocrine Gland Neoplasms,Nervous System Neoplasms,Skin Neoplasms,Head and Neck Neoplasms,Abdominal Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001179 The Foundation Medicine adult cancer clinical dataset consists of 18,004 unique solid tumor samples that underwent genomic profiling on a single uniform platform as part of standard clinical care. The dataset is derived from the FoundationOne® genomic profiling assay version 2 that interrogates exonic regions of 287 cancer-related genes and selected introns from 19 genes known to undergo rearrangements in human cancer. Genomic DNA samples were sequenced to over 500x median coverage, and custom computational analyses identified all classes of genomic alterations (base substitutions, insertions and deletions, copy number alterations, and rearrangements). Since matched normal tissue was unavailable for analysis, these data underwent additional filtering to enrich for cancer-related events. The reported data includes genomic alterations that are known and suspected tumor drivers, as well as variants of unknown significance. To preserve patient anonymity, all known or suspected germline variants were removed from the data unless known to be associated with cancer development. The dataset contains genomic alteration profiles generated by FoundationOne version 2 testing for adult cancer patients (over 18 y.o.), and represents a vast diversity of tumor subtypes, including many rare diseases not profiled as part of large-scale profiling efforts. Cases are grouped into 16 broad disease categories containing tumors from 162 unique disease subtypes. Since specimens were profiled as part of clinical care, limited clinical parameters were available, including age, gender, tissue of origin, % of tumor nuclei, and diagnosis. Publication of this dataset is intended to allow the broad scientific community access to this unique cohort for use in scientific research projects of common and rare types of cancer, both for generating leads regarding causal mechanisms as well as cross-testing and confirming existing hypotheses. A pediatric cancer clinical dataset consisting of data from 1,215 patients under 18 y.o. is available separately at: FOUNDATION MEDICINE

pht005673.v1.p1

1 itemgroup 2 items

pht005668.v1.p1

1 itemgroup 2 items

E1305 Sensory Neuropathy Form NCT00588770

- 7/8/15 - 1 form, 7 itemgroups, 22 items, 1 language

Itemgroups: Header, Patient demographics, Data amendment, OFF TREATMENT, Adverse Events, NON-HEMATOLOGIC, Footer Module

E1305 Sensory Neuropathy Form NCT00588770 Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3EFA1187-27D1-22F1-E044-0003BA3F9857

Eligibility Carcinoma of Unknown Primary NCT00388024

- 1/25/17 - 1 form, 1 itemgroup, 18 items, 1 language

Itemgroup: Criteria

PET Scans and CT Scans in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00388024

Eligibility Carcinoma, Squamous Cell NCT00671437

- 9/27/21 - 1 form, 2 itemgroups, 12 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00671437

Eligibility Carcinoma, Squamous Cell of the Head and Neck NCT00753038

- 9/27/21 - 1 form, 2 itemgroups, 16 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00753038

Eligibility Head and Neck Squamous Carcinoma NCT00634595

- 9/17/21 - 1 form, 2 itemgroups, 13 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Trial of E10A in Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00634595

Eligibility Head and Neck Squamous Cell Carcinoma NCT00957853

- 6/11/20 - 1 form, 2 itemgroups, 15 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Preoperative Treatment With Cetuximab and/or IMC-A12; ODM derived from: https://clinicaltrials.gov/show/NCT00957853

Eligibility Head and Neck Squamous Cell Carcinoma NCT01484847

- 6/11/20 - 1 form, 2 itemgroups, 18 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01484847

Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT00911326

- 6/10/20 - 1 form, 2 itemgroups, 20 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00911326

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