Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Carcinoma, Verrucous

Squamous Cell Carcinoma of Head and Neck

Tongue Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Tongue Cancer

Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.

Comparison of surgical margins using COE vs. DVFE

fluorescence imaging

biopsy

examination

Comparison of surgical margins by COE vs. DVFE

Kristin McNamara, DDS, MS

This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.

PRIMARY OBJECTIVES:

I. To assess the diagnostic benefit of the VELscope (direct visual fluorescence) inspection in oral examination.

II. Efficacy of the VELscope in identifying dysplastic (premalignant) and malignant oral mucosal lesions and in discriminating these lesions from common benign tissue changes.

III. Accuracy of clinical judgment versus VELscope findings. IV. Ability of the VELscope to identify lesions or extent of lesions beyond what is clinically apparent.

OUTLINE:

Patients undergo conventional oral examination (COE) followed by direct visual fluorescence examination (DVFE). Patients with tissue abnormalities found by COE or DVFE undergo scalpel biopsy within 2 weeks.

Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care

The Role of Direct Visual Fluorescence in Oral Examination

Will be evaluated by calculating sensitivity and specificity and their corresponding exact 95% confidence intervals. Association between the two techniques will be assessed using the simple kappa statistic.

Will be evaluated using the dependent t-test. In the event that the parametric requirements of this test are not met, the Wilcoxon, matched-pairs, signed-ranks test will be used.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Breast Diseases

Skin Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

active surveillance

educational intervention

long-term screening

Surendra S. Shastri, MD

RATIONALE: Health education programs and screening methods, such as clinical breast examination and examination of the cervix, may help reduce the number of women who develop breast cancer and cervical cancer.

PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and cervical cancer in women in India.

OBJECTIVES:

* To investigate the effectiveness of well planned health education programs (HEP) and low-cost screening methods (e.g., clinical breast examination \[CBE\] and visual inspection of the cervix painted with 4% acetic acid \[VIA\]) in down-staging and reducing the incidence of and mortality due to breast and cervical cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

* Arm I (intervention): Participants undergo intervention comprising health education programs (HEP), clinical breast examination (CBE), and visual inspection of the cervix painted with 4% acetic acid (VIA) every 2 years for up to 8 years. Participants also undergo active surveillance over 8 years.
* Arm II (control): Participants receive one HEP. Participants also undergo active surveillance over 8 years.

Early Detection of Breast Cancer and Cervical Cancer in Women in India

Early Detection of Common Cancers in Women in India

National Cancer Institute (NCI)

Tata Memorial Hospital

Symptoms and General Pathology

Frailty

questionnaire administration

cognitive assessment

management of therapy complications

Contact Person

Dirk Schrijvers, MD, PhD

RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.

PURPOSE: This clinical trial is studying testing for fitness to undergo chemotherapy to see how well it works in predicting treatment outcomes in older patients with cancer.

OBJECTIVES:

* To assess the feasibility of applying screening tools (Groningen Frailty Indicator \[GFI\] and G8) and their relationship to treatment outcome in older patients with cancer undergoing standard treatment versus geriatric interventions.
* To compare the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA).
* To evaluate the predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity.
* To identify patients that can benefit from a geriatric intervention in order to be able to undergo standard anticancer treatment.

OUTLINE: This is a multicenter study.

All patients complete screening questionnaires (GFI, G8, and the standardized CGA which consists of the ADL (Katz index) and IADL; the Timed Up and Go; the Cancer and Leukemia Group B adaptation of Charlson Co-morbidity; the Mini Nutritional Assessment; the RAND Social Support Survey Instrument; the Folstein Mini Mental State Examination; and the Geriatric Depression Scale) before the start of anticancer treatment, prior to each course of treatment, and after 1 month of treatment. Patients also undergo physical and cognitive performance measures by a trained member of the research team. Patients are assigned to a group based on fitness for treatment. They may be reassigned after each round of assessments.

* Group 1 (fit to undergo standard treatment): Patients undergo standard treatment.
* Group 2 (vulnerable): Patients receive specialized care and individualized treatment.
* Group 3 (frail): Patients receive palliative care and no anticancer chemotherapy or targeted agents.

Patients' medical history, vital signs, performance status, physical examination, and body weight are obtained and recorded. In patients receiving anticancer treatment, all adverse events are graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and recorded and serious adverse events will be reported according to European Rules.

Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment

Impact of Frailty in Senior Cancer Patients: Feasibility and Value of Screening Tools and Geriatric Intervention and Predictive Value of a Screening Tool in Relation to Treatment Outcome

Ziekenhuis Netwerk Antwerpen (ZNA)

Melanoma

Lentigo

Hutchinson's Melanotic Freckle

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Lentigo Maligna Melanoma

Acral Lentiginous Melanoma

Nodular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

gene expression analysis

mutation analysis

immunohistochemistry staining method

laboratory biomarker analysis

mutation carrier screening

study of high risk factors

Julia Newton Bishop, MD

RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.

PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.

OBJECTIVES:

Primary

* Determine what lifestyle factors and which genes govern relapse from melanoma.

Secondary

* Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
* Assess how unusual moles relate to sun exposure and genes that cause melanoma.

OUTLINE: This is a multicenter, cohort study.

Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients\* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).

NOTE: \*Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.

Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.

Patients and healthy participants are followed annually.

Peer reviewed and funded or endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.

Study of Families With Melanoma

Melanoma Family Case-Control Study Protocol

Leeds Cancer Centre at St. James's University Hospital

Gland and Hormone Related Diseases

Ear, Nose, and Throat Diseases

Nervous System Diseases

Digestive System Diseases

Substance Related Disorders

Wounds and Injuries

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hearing Loss

Deafness

Liver Neoplasms

Sarcoma

Teratoma

Brain Neoplasms

Osteosarcoma

Central Nervous System Neoplasms

Medulloblastoma

Neuroblastoma

Testicular Neoplasms

Nervous System Neoplasms

Ototoxicity

Hepatoblastoma

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Neuroepithelial

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Glioma

Ear Diseases

Otorhinolaryngologic Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Germ Cells Tumors

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Medulloblastoma, Childhood

Extragonadal Germ Cell Tumor

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Cisplatin

Liver Extracts

Sodium thiosulfate

Antidotes

Protective Agents

Antioxidants

Antitubercular Agents

Anti-Bacterial Agents

Chelating Agents

Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.

Patients do not receive sodium thiosulfate.

sodium thiosulfate

Patients undergo audiological assessments periodically

David R. Freyer, DO, MS

RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss.

PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.

OBJECTIVES:

Primary

* To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.

Secondary

* To compare the mean change in hearing thresholds for key frequencies in these patients.
* To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia in these patients.
* To compare the event-free survival and overall survival of these patients.
* To evaluate the association of two key gene mutations (TPMT and COMT) with the development of cisplatin-induced hearing loss in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior cranial radiation (yes vs no), age (\< 5 years vs ≥ 5 years) and duration of cisplatin infusion (\< 2 hours vs ≥ 2 hours). Patients are randomized to 1 of 2 arms.

* Arm I (sodium thiosulfate): Patients receive sodium thiosulfate IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.
* Arm II (observation): Patients do not receive sodium thiosulfate.

Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment. Some patients may undergo saliva collection for DNA studies.

After completion of study, patients are followed periodically for 10 years.

Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy

A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.

Mean change in hearing threshold (post-pre) at 500 hz.

Mean change in hearing threshold (post-pre) at 1000 hz.

Mean change in hearing threshold (post-pre) at 2000 hz

Mean change in hearing threshold (post-pre) at 4000 hz.

Mean change in hearing threshold (post-pre) at 8000 hz.

Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.

Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.

Children's Oncology Group

Serious Adverse Events were reported on this study via the NCI AERS reporting system. Per protocol, no expedited reports were submitted for patients on Observation only arm of the study. Thus, no patients enrolled on the Observation arm of the trial were at risk for having a Serious Adverse Event reported.

STS Arm (Sodium Thiosulfate Treatment)

Observation Arm

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

United States

Region of Enrollment

Data was and never will be collected for Outcome Measure #9, Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT).

Results Reporting Coordinator

55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation.

Incidence of Hearing Loss

38 eligible patients in the STS arm had paired audiometry at 500 hz; 45 patients in the observation arm had paired audiometry at 500 hz.

Change in Hearing Thresholds For Key Frequencies at 500 hz

37 eligible patients in the STS arm had paired audiometry at 1000 hz; 47 patients in the observation arm had paired audiometry at 1000 hz.

Change in Hearing Thresholds For Key Frequencies at 1000 hz

38 eligible patients in the STS arm had paired audiometry at 2000 hz; 47 patients in the observation arm had paired audiometry at 2000 hz.

Change in Hearing Thresholds For Key Frequencies at 2000 hz

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care	NCT01816841	Lip and Oral Ca... Oral Cavity Ver... Stage 0 Lip and... Tongue Cancer	fluorescence im... biopsy examination Comparison of s...	18 Years -	Ohio State University Comprehensive Cancer Center
Early Detection of Breast Cancer and Cervical Cancer in Women in India	NCT00632047	Breast Cancer Cervical Cancer	active surveill... educational int... examination long-term scree...	35 Years - 64 Years	National Cancer Institute (NCI)
Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment	NCT01005693	Unspecified Adu...	questionnaire a... cognitive asses... examination management of t...	65 Years -	National Cancer Institute (NCI)
Study of Families With Melanoma	NCT00445783	Melanoma (Skin)	gene expression... mutation analys... immunohistochem... laboratory biom... examination mutation carrie... study of high r...	18 Years -	National Cancer Institute (NCI)
Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy	NCT00716976	Brain Tumor Central Nervous... Childhood Germ ... Extragonadal Ge... Liver Cancer Neuroblastoma Ototoxicity Ovarian Cancer Sarcoma	sodium thiosulf... examination	1 Year - 18 Years	Children's Oncology Group

Spots Global Cancer Trial Database for examination

Every month we try and update this database with for examination 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 examination

Every month we try and update this database with for examination 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 examination 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.