Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Breast Neoplasms

Brain Neoplasms

Genital Neoplasms, Female

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients undergo collection of blood or saliva sample for genetic testing.

Biospecimen Collection

Genetic Testing

Clinical Trials Referral Office

Niloy J. Samadder, M.D.

Jeremy C. Jones, M.D.

This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.

PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics.

SECONDARY OBJECTIVES:

I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:

Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel testing.

Ib. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network \[NCCN\]) based approach for genetic evaluation.

OUTLINE:

Patients undergo collection of blood or saliva sample for genetic testing.

Cancer Genetic Testing in Ethnic Populations

GEMINI - Cancer Genetic Testing in Ethnic Populations

Will identify the prevalence of pathogenic germline mutations in enrolled patients within each cancer site, age (\< 60 years old versus (vs.) \>= 60 years old), and stage (early vs. advanced) via descriptive statistics.

Will determine whether the prevalence of positive pathogenic germline mutations differs between cancer sites, age of diagnosis, and stage of diagnosis using logistic regression analysis across all cancer site groups and pairwise post-hoc analyses using Tukey's correction for multiple comparisons across pairs of cancer sites and chi-square tests of differences between age and stage groups.

Will compare the rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria within cancer site, age, and stage using logistic regression and pairwise post-hoc analyses as needed.

Will assess the impact of germline genetic testing on both therapeutic management and targeted cancer prevention in family members using logistic regression and pairwise post-hoc analyses as needed.

Mayo Clinic

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Prostatic Neoplasms

Urinary Bladder Neoplasms

Melanoma

Nausea

Sarcoma

Testicular Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Male Urogenital Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neoplasms, Connective and Soft Tissue

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Emetics

Gastrointestinal Agents

Coal Tar

Genitourinary medical oncologists and study coordinators will identify patients with genitourinary cancers (i.e., bladder cancer, prostate cancer, and testicular cancer) who will receive moderate to high emetogenic chemotherapy regimen.

Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy.

Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy.

Blood and Tissue

Komal P. Singh, Ph.D., R.N.

Cindy Tofthagen, Ph.D., R.N.

Daniel (Dan) S. Childs, M.D.

The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.

The long-term goal of this study is to alleviate the occurrence of CIN and to improve chemotherapy treatment outcomes. The identification of associations between CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie CIN. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate CIN.

Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy.

Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy. The blood sample will be used for several assays that include gene expression, immune cell profiling, metabolite analytics, and additional omics assays.

Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics

Investigation of Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics

Evaluate the feasibility of patient recruitment by using descriptive statistics to determine number of patients approached and number of patients enrolled.

Evaluate the feasibility of patient retention by using descriptive statistics to determine number of patients who completed the questionnaires at both assessments.

Evaluate the feasibility of patient specimen collection by using descriptive statistics to determine number patients who provided stool samples at both assessments.

Evaluate for changes in alpha and beta diversity as well as composition of the gut microbiome pre- and post-chemotherapy in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Region V3-V5 of the 16s rRNA gene will be targeted for sequencing and submitted to trimmomatic for reads trimming and quality control.

Examine associations between microbial composition functional profiles pre- and post-chemotherapy in patients who report chemotherapy-induced nausea (CIN) after chemotherapy. Change in relative abundance of genus associated with CIN occurrence will be used to predict the function of the genus. We will use PiCrust to perform functional profiling.

Evaluate for differentially abundant metabolites associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling of stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Evaluate for perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling will be performed on stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS), as well as RNA-Seq analyses.

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Lung Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Acute Graft Versus Host Disease

Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.

Quality-of-Life Assessment

Questionnaire Administration

Steven J. Frank

Steven J Frank

This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.

PRIMARY OBJECTIVES:

I. To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.

II. To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.

SECONDARY OBJECTIVES:

I. To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.

II. To document and compare symptom burden weekly during treatment and twice a month for 3 months after therapy, using the M.D. Anderson Symptom Inventory (MDASI).

OUTLINE:

Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.

Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy

Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults

Data will be collected from all organs receiving non-negligible proton dose during treatment. For each acute normal-tissue endpoint considered, analyses will be performed using the maximum toxicity score per patient within the 90-day follow-up. Upon analysis, the distribution of observed toxicity scores for each acute normal-tissue endpoint will be reported.

Data will be collected from all organs receiving non-negligible proton dose during treatment. For each late normal-tissue endpoint considered, analyses will be performed using censored time-to-event data corresponding to specified levels of injury (e.g. time to a specific grade \>= 2 late toxicity). The log-rank test will be used to compare event times in subgroups of patients with different dosimetric characteristics of treatment (e.g. portion of lung receiving \> 20 Gy: \<= 40% vs \> 40%). In addition, normal-tissue complication probability models will be fitted to data corresponding to incidence of a late endpoint within a specified time frame, with analysis limited to patients having the specified follow-up (e.g. incidence of grade \>= 2 late rectal bleeding within 2 years among patients followed for 2 years post-treatment).

Relevant dose-volume response models from the literature, such as the Lyman model, the parallel model, or the critical-element model will be fitted to the data when possible, and model parameter estimates reported. Confidence intervals for model parameter estimates will be derived using the profile-likelihood method.

Will be documented and compared using the M.D. Anderson Symptom Inventory (MDASI). The initial analysis for symptom data will be primarily descriptive in nature, and will include frequencies, proportions, means, medians, standard deviations, ranges, interquartile ranges, confidence intervals for the means, and box and whisker plots. Potential differences in symptom development between patients and between treatment variables will be explored using longitudinal analysis performed with mixed models.

M.D. Anderson Cancer Center

Before surgery, patients complete a functional and nutritional assessment. The home environment of patients will also be assessed. Based on findings, patients undergo personalized prehabilitation. Patients also wear an actigraph throughout the study to measure and record daily steps taken and sedentary time. Patients use the TapCloud app on a smart device (phone, tablet) or home computer to collect, track, and report their symptoms. Based on patient input in the TapCloud app, a real-time alert is sent to an RN when predetermined thresholds are met. RNs then contact the patient via the TapCloud app and further phone calls if necessary. Patients, caregivers and surgeons may also participate in a focus group in-person, via telephone, or videoconferencing.

Patients and their families meet with the surgeon at least once before surgery. After surgery, patients are managed daily during post-operative care. Patients may receive a referral for functional and nutritional prehabilitation at the discretion of the surgeon/surgical team. Patients and their families receive instructions to follow the standard procedures for reporting problems between clinic visits, including contacting their surgical team if symptoms become severe and physical function worsens; and the use of the hospital call line to report problems. Patients, caregivers and surgeons may receive the opportunity to participate in focus group in-person, via telephone, or videoconferencing.

Participate in a surgeon-only perioperative care program

Best Practice

Functional Assessment

Medical Device Usage and Evaluation

Nutritional Assessment

TapCloud

Virginia Sun

This phase III trial compares a home-based telemonitoring program that collects symptom and daily step information to surgeon only care in improving recovery and stopping complications within 30 days after surgery in patients with gastrointestinal, genitourinary, or gynecologic cancer who are scheduled to undergo abdominal surgery. Patients may experience a decrease in functional capacity and experience symptoms like pain and fatigue after surgery, and this may change their ability to walk and function. Home-based telemonitoring of patient symptoms and their ability to walk and function after surgery may help doctors and nurses find and treat problems early, which may improve the patient's recovery and lower the number of complications after surgery.

PRIMARY OBJECTIVES:

I. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on clinically significant changes in functional recovery (accelerometer daily step count) and related secondary patient-centered outcomes (sleep, sedentary time, symptom severity, symptom interference with daily activities).

II. Compare the impact of remote perioperative telemonitoring care versus surgeon only perioperative care on postoperative complications (Comprehensive Complications Index - CCI) and related secondary surgical outcomes (hospital readmission).

III. Compare early withdrawal (dropout or loss of accelerometer device) between the comparators.

IV. Explore perioperative telemonitoring care-related experiences (acceptability, technology usability, uptake/integration) among patients, families, and surgeons through qualitative focus groups and exit interviews.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (REMOTE PERIOPERATIVE TELEMONITORING CARE GROUP): Before surgery, patients complete a functional and nutritional assessment. The home environment of patients will also be assessed. Based on findings, patients undergo personalized prehabilitation. Patients also wear an actigraph throughout the study to measure and record daily steps taken and sedentary time. Patients use the TapCloud application (app) on a smart device (phone, tablet) or home computer to collect, track, and report their symptoms. Based on patient input in the TapCloud app, a real-time alert is sent to a registered nurse (RN) when predetermined thresholds are met. RNs then contact the patient via the TapCloud app and further phone calls if necessary. Patients, caregivers and surgeons may also participate in a focus group in-person, via telephone, or videoconferencing.

GROUP II (SURGEON ONLY PERIOPERATIVE CARE GROUP): Patients and their families meet with the surgeon at least once before surgery. After surgery, patients are managed daily during post-operative care. Patients may receive a referral for functional and nutritional prehabilitation at the discretion of the surgeon/surgical team. Patients and their families receive instructions to follow the standard procedures for reporting problems between clinic visits, including contacting their surgical team if symptoms become severe and physical function worsens; and the use of the hospital call line to report problems. Patients, caregivers and surgeons may receive the opportunity to participate in focus group in-person, via telephone, or videoconferencing.

After completion of study, patients are followed up for 3-4 months.

Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery

Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional Recovery and Symptoms

Will calculate percent change from preoperative baseline in daily step count during the first 2 weeks post-discharge from hospital. Will use generalized linear mixed modeling (with treatment and covariates as fixed factors, patient identification as random factor).

Analyzed using proportional hazards regression.

Qualitative data from exit interviews and focus groups will be analyzed using the conventional content analysis approach.

Assessed using the Comprehensive Complications Index (CCI) which summarizes the entire patient postoperative experience with respect to complications (on a scale from 0 to 100), and is based on the established Clavien-Dindo classification. For CCI score: Higher = worse

Maximum CCI will be categorized as above versus below 15, and logistic regression will be used to evaluate the effect of study intervention.

Assessed using the Actigraph GT9X Link. Data capture will focus on the following: 1) number of steps taken per day and 2) sedentary time. Recommended activity counts per minute (cpm) cutpoints will be used to categorize sedentary time (\< 100 cpm) from light-intensity physical activity (100-1951 cpm) and moderate/vigorous intensity physical activity (\>=1952 cpm).

Assessed using the MD Anderson Symptom Inventory.

Assessed using the MD Anderson Symptom Library Items.

Patient-Centered Outcomes Research Institute

National Cancer Institute (NCI)

City of Hope Medical Center

Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed. Please see above regarding adverse events.

Before surgery, patients complete a functional and nutritional assessment. The home environment of patients will also be assessed. Based on findings, patients undergo personalized prehabilitation. Patients also wear an actigraph throughout the study to measure and record daily steps taken and sedentary time. Patients use the TapCloud app on a smart device (phone, tablet) or home computer to collect, track, and report their symptoms. Based on patient input in the TapCloud app, a real-time alert is sent to an RN when predetermined thresholds are met. RNs then contact the patient via the TapCloud app and further phone calls if necessary. Patients, caregivers and surgeons may also participate in a focus group in-person, via telephone, or videoconferencing.

Functional Assessment: Complete a functional assessment

Medical Device Usage and Evaluation: Wear an actigraph

Nutritional Assessment: Complete a nutritional assessment

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

TapCloud: Use TapCloud app

Group I (Telemonitoring Program, Actigraph, TapCloud)

Patients and their families meet with the surgeon at least once before surgery. After surgery, patients are managed daily during post-operative care. Patients may receive a referral for functional and nutritional prehabilitation at the discretion of the surgeon/surgical team. Patients and their families receive instructions to follow the standard procedures for reporting problems between clinic visits, including contacting their surgical team if symptoms become severe and physical function worsens; and the use of the hospital call line to report problems. Patients, caregivers and surgeons may receive the opportunity to participate in focus group in-person, via telephone, or videoconferencing.

Best Practice: Participate in a surgeon-only perioperative care program

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Group II (Surgeon-only Perioperative Care Program)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Virginia Sun, Professor

Change in Daily Step Count

Time to Early Withdrawal

Qualitative Data

398 participants were enrolled to the study, however 16 participants did not want to participate after signing consent and are considered attrition which is the reason why data analysis was done for 382 participants instead of the total consented/enrolled. These number are accurate for analysis based on the data collection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Genetic Testing in Ethnic Populations	NCT04475640	Breast Carcinom... Carcinoma of Un... Central Nervous... Digestive Syste... Genitourinary S... Head and Neck C... Malignant Brain... Malignant Femal... Malignant Muscu... Malignant Solid... Skin Carcinoma	Biospecimen Col... Genetic Testing	18 Years -	Mayo Clinic
Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics	NCT05819827	Bladder Cancer Prostate Cancer Testicular Canc... Bladder Carcino... Genitourinary S... Malignant Testi... Melanoma Prostate Carcin... Sarcoma	Blood and Tissu...	20 Years -	Mayo Clinic
Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy	NCT00991094	Breast Carcinom... Esophageal Carc... Genitourinary S... Head and Neck C... Hematopoietic a... Lung Carcinoma Malignant Centr... Malignant Diges... Malignant Solid...	Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics	NCT05819827	Bladder Cancer Prostate Cancer Testicular Canc... Bladder Carcino... Genitourinary S... Malignant Testi... Melanoma Prostate Carcin... Sarcoma	Blood and Tissu...	20 Years -	Mayo Clinic
Home Base Telemonitoring in Gastrointestinal, Genitourinary, or Gynecologic Cancer Patients Undergoing Abdominal Surgery	NCT04596384	Digestive Syste... Genitourinary S... Malignant Femal... Malignant Solid...	Best Practice Functional Asse... Medical Device ... Nutritional Ass... Quality-of-Life... Questionnaire A... TapCloud	18 Years -	City of Hope Medical Center
Cancer Genetic Testing in Ethnic Populations	NCT04475640	Breast Carcinom... Carcinoma of Un... Central Nervous... Digestive Syste... Genitourinary S... Head and Neck C... Malignant Brain... Malignant Femal... Malignant Muscu... Malignant Solid... Skin Carcinoma	Biospecimen Col... Genetic Testing	18 Years -	Mayo Clinic
Cancer Genetic Testing in Ethnic Populations	NCT04475640	Breast Carcinom... Carcinoma of Un... Central Nervous... Digestive Syste... Genitourinary S... Head and Neck C... Malignant Brain... Malignant Femal... Malignant Muscu... Malignant Solid... Skin Carcinoma	Biospecimen Col... Genetic Testing	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for genitourinary system carcinoma