Symptoms and General Pathology

All Conditions

Pathologic Complete Response

Disease Progression

Disease Attributes

Patients with locally advanced (T3-4NxM0) rectal adenocarcinoma

Eligible patients will be prospectively enrolled, and images of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative magnetic resonance imaging (MRI) scans, histopathology slides stained with hematoxylin and eosin (H\&E), carcinoembryonic antigen (CEA), and circulating tumor DNA (ctDNA) will be collected and annotated.

Medical examination

Jun Huang

Meijin Huang

The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is:

What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated.

This is a single-center, prospective, observational phase II clinical study aimed at validating a dynamic multi-omics (imaging, pathology, molecular biomarkers) integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer. Specifically, the study aims to validate the predictive accuracy of the dynamic multi-omics prediction model and determine whether it outperforms other conventional prediction models based on single-modality imaging, pathology, and molecular biomarkers.

Eligible patients will be prospectively enrolled, and images of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative magnetic resonance imaging (MRI) scans, histopathology slides stained with hematoxylin and eosin (H\&E), carcinoembryonic antigen (CEA), and circulating tumor DNA (ctDNA) will be collected and annotated. MRI, H\&E images, CEA, ctDNA, and their change features will be applied to the prediction model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment. The predictive results will be further compared with the pathological tumor response obtained from resected specimens.

Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer

A Study of the Clinical Value of Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer (T3-4NxM0)

negative predictive value of prediction model

positive predictive value of prediction model

Sixth Affiliated Hospital, Sun Yat-sen University

Neoplasms

Blood and Lymph Conditions

Head and Neck Neoplasms

Lymphedema

Fibrosis

Lymphatic Diseases

Participants will be evaluated for LEF status using the HN-LEF Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including VHNSS and LSIDS-H\&N. Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.

Evaluation of secondary lymphedema and fibrosis (LEF) status

Medical Examination

Questionnaire Administration

Undergo ultrasound shear wave elastrography

Shear Wave Elastography

Kenneth Niermann

This research trial studies skin/soft tissue elasticity in head and neck cancer survivors with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck cancer which may lead to skin tightness, pain, and body image issues. Early detection of lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave elastography is a technique that provides a quantitative measure of stiffness using a push pulse to generate shear waves within the tissues. Conventional imaging techniques are then used to monitor the shear waves generated through the tissue to calculate the shear wave speed. Shear wave elastography may help obtain an early and accurate measurement of tissue elasticity in head and neck cancer survivors.

PRIMARY OBJECTIVES:

I. To obtain pilot data of the elasticity of skin/soft tissues using shear wave elasticity at the defined anatomical sites in head and neck cancer survivors with lymphedema and fibrosis (LEF).

II. To explore the correlation between elasticity of skin/soft tissues and the following: 1) symptoms as measured by the Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN); 2) functional impact as measured by Cervical Range of Motion Device and the Vanderbilt Head and Neck Symptom Survey; and 3) physical exam findings as measured by Head and Neck LEF Grading Criteria.

OUTLINE:

Participants will be evaluated for LEF status using the Head and Neck External Lymphedema - Fibrosis (HN-LEF) Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including Vanderbilt Head and Neck Symptom Survey (VHNSS) and Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H\&N). Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.

Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis

Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors

Descriptive statistics will be used to describe data from elasticity measure. Of particular interest will be the measures of central tendency and variability at the multiple sites. Sites with higher variability (coefficient of variation) that others may be indicative of less reliable assessment.

Correlation coefficients will be used to assess the strength of the associations of the elasticity values with the respective LEF grades (HN-LEF) for the respective sites. Those values will also be correlated with Vanderbilt Head and Neck Symptom Survey and HN-LSIDS symptom and Cervical Range of Motion scores. Due to the large number of correlations proposed in this study, effect sizes (strength of the associations) and clinically significant patterns will be of much greater importance than statistical significance.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Micronutrients

Vitamins

Insulin

Insulin, Globin Zinc

Hormones

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Trace Elements

Antioxidants

Protective Agents

Tocopherol

Tocotrienol

Subjects will be asked to consume a standard Western Diet for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).

Subjects will be asked to consume a low fat diet with fish oil and vitamin E supplements for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).

Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.

Fish Oil

Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.

Vitamin E supplement

Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.

Western Diet

Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.

Low-Fat Diet

Subjects will have a routine medical exam.

Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.

Dietary Interview

40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.

Blood Draw

Subjects will undergo a radical prostatectomy as part of their standard of care.

Radical Prostatectomy

William Aronson, MD

Studies on patterns of how many men get prostate cancer in other countries show that environment contributes to the high incidence of prostate cancer in the United States. Epidemiology studies suggest that this influence may be reduced by the diet of men at risk of getting prostate cancer. Although the exact nature of the effects of diet are not completely known, the amount of fat eaten appears to affect the number of men who get prostate cancer. The type of fat also seems to matter. Eating more of a type of fat called omega-3 polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat comes from fish and is quite different from the type of fat from animals and vegetables (omega-6 fat). Because the exact mechanism of this reduction in prostate cancer risk is not known, no blood test indications, called markers, have been discovered that would show the effect working.

Study doctors designed this study to try to find markers in the blood tests of men who have prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil helps reduce those markers, hence indicating that it helps reduce the cancer in these men. These men will be compared to men with prostate cancer whose diets do not contain the fish-oil fat.

The men chosen will have prostate cancer and be scheduled for operations to have their prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the beginning of the diet. After the 4-to-8-week period, they will have their operations. Their blood will be checked again and a sample of their removed prostate will be examined to tell if the diet had any effect on the cancer and its markers.

1. To establish and validate intermediate biomarkers for prostate cancer prevention trials by conducting a dietary intervention trial of a low-fat diet with omega-3 fatty acid supplements in men undergoing radical prostatectomy. In initial trials it was feasible to intervene with diet and obtain tissue and serum for bioassay and biomarker development. This aim is to study the effect a low-fat, high omega-3 diet has on serum and tissue biomarkers from patients who have prostatectomies for prostate cancer. Ultimately, we hope to identify and validate intermediate markers of efficacy for large-scale dietary prevention trials.
2. To establish and validate insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer prevention trials. IGF-1 is a peptide growth factor that is important to the growth and progression of prostate cancer. To our knowledge, no prospective dietary intervention studies have evaluated the effect of a low-fat diet with omega-3 fatty acid supplements on IGF-1 and IGFBPs, and their potential to serve as relevant intermediate markers for low-fat dietary intervention trials for prostate cancer prevention.
3. To establish and validate serum and tissue fatty acids as relevant intermediate biomarkers for prostate cancer prevention trials. We will evaluate if men randomized to a low-fat, fish-oil-supplemented diet have increased serum ratios of omega-3:omega-6 fatty acids compared with men randomized to a control Western diet before radical prostatectomy. We also will study if patients in the low-fat, fish oil arm have increased ratios of membrane omega-3:omega-6 fatty acids as well as decreased COX-2 and decreased PGE-2 levels in benign and malignant tissue and in visceral fat. If so, it will proved further evidence to support the potential of low-fat fish oil diets for prostate cancer prevention. If serum omega-3:omega-6 ratios correlate with changes in COX-2 and PGE-2 in tissues, then serum omea-3:omega-6 ratios may be useful for monitoring activity and efficacy of low-fat fish-oil-supplemented diets in future trials.

Low-Fat Fish Oil Diet for Prostate Cancer Prevention

Comparison Study of a Low-Fat Diet Supplemented With Fish Oil and a Standard Western Diet in Individuals With Prostate Cancer

Jonsson Comprehensive Cancer Center

Carcinoma

Participants receive standard medical care. Participants complete a DHQ at baseline.

Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo a DRE at baseline and annually for 3 years. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial.

Laboratory Biomarker Analysis

Screening Questionnaire Administration

Christine D Berg

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer.

PRIMARY OBJECTIVES:

I. To determine whether screening with digital rectal examination (DRE) plus serum prostate-specific antigen (PSA) can reduce mortality from prostate cancer in men aged 55-74 at entry.

SECONDARY OBJECTIVES:

I. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.

II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.

IV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.

OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening).

ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.

ARM II (Prostate Screening): Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo a DRE at baseline and annually for 3 years. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal prostate cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with prostate cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.

Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health \[PSH\] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial.

After completion of screening, participants are followed up for at least 13 years.

Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)

Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.

Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.

Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.

Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.

Number of positive screens with complications

These events are solely those prompted by the screening examination.

Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.

Prostate Screening

Participants receive standard medical care.

Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Paul F. Pinsky, Ph.D.

All male participants randomized were analyzed. An intention-to-treat analysis was performed.

Prostate Cancer Deaths

All male participants were analyzed. An intention-to-treat analysis was performed.

Deaths From All Causes

Death Rates From All Causes

Prostate Cancer Incidence

Prostate Cancer Incidence Rates

When DE Led to Prostate Cancer Diagnosis

When DE Did Not Lead to Prostate Cancer Diagnosis

The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.

Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test

Negative (<=4 ng/mL)

Positive (> 4 ng/mL)

Inadequate screen

All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.

T0 (Baseline) PSA Screening Results

Negative

Positive

All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.

T0 (Baseline) DRE Screening Results

All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.

T1 PSA Screening Results

All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.

T1 DRE Screening Results

All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.

T2 PSA Screening Results

All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.

T2 DRE Screening Results

All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.

T3 PSA Screening Results

All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.

T3 DRE Screening Results

Prostate Cancer Death Rates

All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.

T4 PSA Screening Result

All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.

T5 PSA Screening Results

Overall Study

Infections

Immune System Diseases

Communicable Diseases

Papillomavirus Infections

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV DNA, and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo HRA and penile clinical exam at month 12.

Undergo penile skin cell and anal swab collection

Cytology Specimen Collection Procedure

High Resolution Anoscopy with Biopsy

Physical Examination

Joel Palefsky

Sharmila A. Pimple

Vijay Nair

This research trial studies the incidence of human papilloma virus (HPV) infection and HPV-associated disease in screening Indian men who have sex with human immunodeficiency virus (HIV)-positive men. Gathering health information over time from Indian men who have sex with men (MSM) may help doctors determine how many HIV -positive MSM develop new HPV infections and how many HIV-positive MSM have HPV related disease.

PRIMARY OBJECTIVES:

I. Determine the prevalence of HPV-associated premalignant lesions in the anus and penis in Indian HIV-seropositive men who have sex with men (MSM).

SECONDARY OBJECTIVES:

I. Describe risk factors for prevalent premalignant lesions in the anus and penis in Indian HIV-seropositive MSM.

II. Describe the prevalence and incidence of penile and anal HPV infection in Indian HIV-seropositive MSM.

OUTLINE:

Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV deoxyribonucleic acid (DNA), and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.

Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men

Investigating Human Papillomavirus (HPV) Infection and HPV-Associated Disease in Indian Men Who Have Sex With Men Who Are HIV-Positive

The proportion of men with HPV 6, 11, 16, and/or 18-associated HGAIN will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.

Will be calculated using proportions and exact 95% binomial CI.

Will be estimated for specific types, and for all types combined using the life table approach for incidence. Separate estimates will be made for each anatomical site. Risk factors for site-specific incident infection will be evaluated using regression models for survival events observed in discrete time (e.g. pooled logistic regression), incorporating behavioral and biological predictors measured at baseline, and over time at study visits. Risk factors that will be assessed include behavioral and medical history, CD4+ level, and HIV viral load.

The proportion of men with HGAIN at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs .

The proportion of men with premalignant lesions of the penis at baseline according to number of sex partners in the last 6 months will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs.

The proportion of men with HGAIN at baseline according to number of sex partners in the last 6 months will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.

The proportion of men with premalignant lesions of the penis at baseline according to CD4+ level at baseline will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs .

The proportion of men with HGAIN at baseline according to CD4+ level at baseline will be calculated. HGAIN is determined by biopsy and HPV typing is based on concurrent DNA analysis of anal swabs.

The proportion of men with premalignant lesions of the penis at baseline according to presence and absence of HPV infection (types 6, 11, 16, and/or 18) will be calculated. Premalignant lesions of the penis are determined by colposcopic magnification and HPV typing is based on concurrent DNA analysis of penile swabs .

AIDS Malignancy Consortium

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Melanoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients with non-small-cell lung cancer (NSCLC)

Collection of faeces, coproculture examination, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening. Analysis for the identification, quantification and characterization of health-promoting bacteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer	NCT06364371	Predictive Canc... Pathologic Comp...	Medical examina...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis	NCT02676752	Lymphedema	Medical Examina... Questionnaire A... Shear Wave Elas...	22 Years -	Vanderbilt-Ingram Cancer Center
Low-Fat Fish Oil Diet for Prostate Cancer Prevention	NCT00798876	Prostate Cancer	Fish Oil Vitamin E suppl... Western Diet Low-Fat Diet Medical Examina... Dietary Intervi... Blood Draw Radical Prostat...	40 Years - 75 Years	Jonsson Comprehensive Cancer Center
Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)	NCT00002540	Prostate Carcin...	Laboratory Biom... Medical Examina... Screening Quest...	55 Years - 74 Years	National Cancer Institute (NCI)
Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men	NCT04142398	HIV Infection Human Papilloma... Human Papilloma...	Cytology Specim... High Resolution... Laboratory Biom... Medical Examina... Physical Examin... Questionnaire A...	18 Years -	AIDS Malignancy Consortium
Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)	NCT00002540	Prostate Carcin...	Laboratory Biom... Medical Examina... Screening Quest...	55 Years - 74 Years	National Cancer Institute (NCI)
Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)	NCT00002540	Prostate Carcin...	Laboratory Biom... Medical Examina... Screening Quest...	55 Years - 74 Years	National Cancer Institute (NCI)
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Oncologic Diseases	NCT04698161	Non Small Cell ... Metastatic Mela...	Biological samp... Questionnaire Medical examina...	18 Years - 75 Years	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer	NCT06364371	Predictive Canc... Pathologic Comp...	Medical examina...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University

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