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

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Small Cell Lung Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Lung Neoplasms

Lymphoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Small Cell Lung Cancer

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Mitoguazone

Cola

The G-8 consists of eight items: patient age (\>85, 80-85, \<80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was \<=14 and the time taken to complete the test was recorded.

VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score \>=3 was considered to show impairment.

Geriatric screening tests

Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G), recorded the time required for the consultation, identified patients who needed personalized geriatric interventions, and, if necessary, proposed further geriatric evaluation (outside of the scope of this study).

Multidimensional geriatric assessment

Pierre Soubeyran, MD, PhD

RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.

PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.

OBJECTIVES:

Primary

* Validate a new screening tool (G8).

Secondary

* Validate the French version of the screening tool "Vulnerable Elders Survey (VES-13)".
* Evaluate the merits of the screening tools (G8 and VES-13).
* Assess the screening tool in specific populations.
* Assess the number and type of interventions proposed after thorough geriatric assessment.
* Compare the two new tools (G8 vs VES-13).

OUTLINE: This is a multicenter study.

During the first consultation, patients have an initial clinical evaluation questionnaire comprising the G8. They also complete the self-questionnaire VES-13. Within 30 days, patients have a thorough geriatric assessment, including quality of life and physical function, by a physician without access to the G8 or VES-13 questionnaires. A blood specimen is also collected.

Information on health status and quality of life is collected from medical records or from the doctor after 1 and 5 years.

Validation of a Screening Tool in Geriatric Oncology

Sensitivity of the G8 questionnaire measured as Percentage of Participants with a Positive G8 among patients with a positive MGA. The G8 consists of eight items: patient age (\>85, 80-85, \<80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was \<=14.

Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.

Specificity of the G8 questionnaire measured as percentage of participants with a negative G8 test among patients with a negative MGA.The G8 consists of eight items: patient age (\>85, 80-85, \<80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was \<=14.

Multidimensional geriatric assessment (MGA): Patients underwent a geriatric evaluation in the month following the completion of VES-13. The nurse completed six instruments of the MGA (MNA, Timed Get up and Go, Activities of Daily Living (ADL), Instrumental ADL, Mini Mental State Examination, and Geriatric Depression Scale, and the geriatrician rated comorbidity on the Cumulative Illnes Rating Scale.

Sensitivity of the VES-13 questionnaire measured as percentage of participants with a positive VES-13 test among patients with a positive MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score \>=3 was considered to show impairment.

Multidimensional geriatric assessment (MGA): see measure description for primary outcome.

Specificity of the VES-13 questionnaire measure as the percentage of participants with a negative VES-13 test among patients with a negative MGA. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score \>=3 was considered to show impairment.

Multidimensional geriatric assessment (MGA): see measure description for primary outcome.

Reproducibility of G8 was assessed by comparing the score on the actual G8 with the scores extracted from the corresponding seven questions of MNA completed during the MGA for all patients. The G8 consists of eight items: patient age (\>85, 80-85, \<80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was \<=14.

Reproducibility of VES-13 was assessed based on a subgroup of patients included in three pre-identified centers who completed the questionnaire on two occasions. VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For 3 pre-identified centers, patients filled in the questionnaire at the following geriatric visit. VES-13 consisted of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score \>=3 was considered to show impairment.

National Cancer Institute, France

Institut Bergonié

Screening tests (G8 and VES-13)

The G-8 consists of eight items: patient age (\>85, 80-85, \<80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and selfrated health). The total score ranges from 0 to 17, with lower scores indicating a higher risk of impairments. The cut-off value for an 'impaired' reference test score was \<=14.

VES-13 is a self-administered questionnaire that was completed during the first visit after enrollment. For three pre-identified centers, patients also filled in the questionnaire at the following geriatric visit. VES-13 consisted of four groups of questions: age, self-perceived health, difficulties to perform six specific activities, and difficulties to perform daily living tasks due to health concerns. The score ranged from 0 to 10 and a score \>=3 was considered to show impairment.

Multidimensional geriatric assessment: Patients underwent a geriatric evaluation in the month following the completion of G8 and VES-13 (+/- seven days) before treatment began. The nurse completed six of the seven instruments of the MGA (MNA, Timed Get up and Go (TUG), Activities of Daily Living (ADL), Instrumental ADL (IADL), Mini Mental State Examination (MMSE), and Geriatric Depression Scale (GDS-15)), and the geriatrician rated comorbidity on the Cumulative Illness Rating Scale (CIRS-G).

Included Patients

Patients older than 70 years and were included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)).

Eligible Patients

70-74 years

75-79 years

80-84 years

85 years and older

Age, Customized

Sex: Female, Male

France

Region of Enrollment

Baseline analysis population is restricted to eligible patients only.

Pr Pierre Soubeyran

Patients older than 70 years and included either before any first-line treatment, or between any two steps of a pre-defined first-line treatment sequence (chemotherapy, endocrine therapy, targeted treatment, surgery or radiotherapy) for various types of histologically-confirmed cancer (colon, lung, upper aero digestive tract (UAT)/head and neck, breast, prostate, and non-Hodgkin's lymphomas (NHL)), and for whom G8 as well as at least one instrument of the multidimensional assessment were available.

Eligible Patients Assessable for the Primary Outcome Measure

Eligible patients assessable for the primary outcome measure AND with a positive MGA

Sensitivity of the G8 Questionnaire

Eligible patients assessable for the primary outcome measure AND with a negative MGA

Specificity of the G8 Questionnaire

Eligible Patients Assessable for the Primary Outcome Measure AND with a positive VES-13

Sensitivity of the VES-13 Questionnaire

Eligible patients assessable for the primary endpoint (sensitivity of the G8 questionnaire) and with a negative MGA

Specificity of the VES-13 Questionnaire

Eligible Patients Assessable for the Primary Outcome Measure AND with two assessments of the G8 available

Reproducibility of the G8 Questionnaire

Eligible Patients Assessable for the Primary Outcome Measure AND with two assessments of the VES-13 available

Reproducibility of the VES-13 Questionnaire

Overall Study

Precancerous Conditions

Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

vandetanib

placebo

immunohistochemistry staining method

laboratory biomarker analysis

pharmacological study

Tanguy Seiwert, M.D.

This randomized phase II trial studies how well vandetanib works in preventing head and neck cancer in patients with precancerous head and neck lesions. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vandetanib may keep cancer from forming in patients with premalignant lesions

PRIMARY OBJECTIVE:

I. Determine the effect of ZD6474 (vandetanib) compared to placebo on microvessel density (MVD) from baseline to 3 months in patients at risk for oral squamous cell carcinoma (OSCC) with preneoplastic lesions.

SECONDARY OBJECTIVES:

I. Change in MVD over 6 months. II. Change in putative targets of ZD6474: tissues will be analyzed by immunohistochemistry (IHC) for phosphorylated epidermal growth factor receptor (pEGFR), EGFR, phosphorylated-vascular endothelial growth factor receptor 2 (pVEGFR2), VEGFR2.

III. Change in proliferative index as measured by Ki-67 IHC. IV. Safety, tolerability, and adherence to ZD6474 for 6 months in patients at risk for OSCC.

TERTIARY OBJECTIVES:

I. Compare OSCC incidence in both study arms (ZD6474 and placebo).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive vandetanib orally (PO) once daily (QD) for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 9 and 12 months and then every 6 months for 2 years.

Vandetanib in Preventing Head and Neck Cancer in Patients With Precancerous Head and Neck Lesions

Randomized Placebo- Controlled Pilot Study of ZD6474 as a Chemopreventive Agent for Premalignant Lesions of the Head and Neck

A Wilcoxon ranksum test may be used if the normality assumption is not satisfied. Alternatively, change in MVD may be transformed (e.g. log-transformation) to satisfy the normality assumption. Additional analyses will include linear regression models with treatment effect and other prognostic factors as covariates.

Adverse events rate shows the total number of subjects with an AE.

Number of participants who Adhered to Treatment

Effect of treatment on EGFR and VEGFR2 inhibition

National Cancer Institute (NCI)

University of Chicago

Adverse Events were monitored/assessed without regard to the specific Adverse Event Term

Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

vandetanib: Given PO

immunohistochemistry staining method: Correlative studies

laboratory biomarker analysis: Correlative studies

biopsy: Correlative studies

pharmacological study: Correlative studies

Arm I (Chemoprevention)

Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

placebo: Given PO

immunohistochemistry staining method: Correlative studies

laboratory biomarker analysis: Correlative studies

biopsy: Correlative studies

pharmacological study: Correlative studies

Arm II (Placebo)

Total

Age, Continuous

Race (NIH/OMB)

United States

Dr. Alexander Pearson

The outcome measure microvessel density was not collected on any subjects

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
Validation of a Screening Tool in Geriatric Oncology	NCT00963911	Breast Cancer Colorectal Canc... Head and Neck C... Lung Cancer Lymphoma Prostate Cancer	Geriatric scree... Multidimensiona...	70 Years - 120 Years	Institut Bergonié
Vandetanib in Preventing Head and Neck Cancer in Patients With Precancerous Head and Neck Lesions	NCT01414426	Lip and Oral Ca... Oral Cavity Ver... Precancerous Co...	vandetanib placebo immunohistochem... laboratory biom... biopsy pharmacological...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for oral cavity verrucous carcinoma