- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06995898
- Original Trial
The Vanguard Study: Testing a New Way to Screen for Cancer
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. Assess the feasibility of recruitment and adherence to protocol-required baseline and follow-up data and blood collection.
II. Assess the feasibility of achieving representative enrollment across participating recruitment sites.
SECONDARY OBJECTIVES:
I. To assess the impact of participant blinding on willingness to participate, adherence to protocol required baseline and follow-up data, blood collection, and rates of standard of care screening.
II. To determine the timeliness of returning test results to participants. III. To understand the factors contributing to lack of diagnostic resolution of an abnormal MCD test.
IV. To examine the effects of participant characteristics, including cancer risk factors and social determinants of health, on all aspects of feasibility.
V. To estimate the proportion of participants receiving an MCD test outside of the trial.
VI. To assess the feasibility of a staggered introduction of the second MCD assay intervention arm.
VII. To estimate the proportion of abnormal MCD tests that are diagnostically resolved, and the time to resolution.
VIII. To compare the proportion of participants who receive standard of care screening during follow-up between the intervention and control arms.
IX. To assess the accuracy of tissue of origin prediction for each MCD assay. X. To estimate the incidence of complications related to diagnostic evaluation of an abnormal MCD test result.
XI. To assess the effect of an abnormal MCD test and diagnostic workup on anxiety and cancer worry.
XII. To evaluate the clinical diagnostic performance of the MCD assays.
EXPLORATORY OBJECTIVES:
I. To estimate rates of late-stage cancer, and the distribution of cancer stage.
II. To estimate assay-targeted cancer-specific mortality of each MCD assay, all cancer-specific mortality, and all-cause mortality.
III. To develop preliminary estimates of the total and incremental budget impact of MCD testing compared to current screening practice from the payor perspective.
IV. To develop preliminary estimates of the economic burden and impact of MCD testing from the participant perspective.
V. To assess the willingness of participants who reported military service to describe military-related environmental exposures by completing the Military Exposure Questionnaire.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
ARM II: Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
ARM III (Control): Participants undergo blood collection at enrollment and after one year on study.
After completion of study intervention, participants are followed passively up to 10 years.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Pleasanton, California, United States, 94588
- Recruiting
- Kaiser Permanente-Division of Research
-
Contact:
- Site Public Contact
- Phone Number: 510-891-3400
-
Principal Investigator:
- Jeffrey Lee
-
-
Colorado
-
Cheyenne Wells, Colorado, United States, 80810
- Recruiting
- Keefe Memorial Hospital
-
Contact:
- Site Public Contact
- Phone Number: 719-767-5661
- Email: cmillsap@keefemh.org
-
Principal Investigator:
- Linda S. Cook
-
Denver, Colorado, United States, 80205
- Recruiting
- Kaiser Permanente-Franklin
-
Principal Investigator:
- Debra P. Ritzwoller
-
Contact:
- Site Public Contact
- Phone Number: 303-817-9295
- Email: KPCOIHRClinicalResearch@kp.org
-
Fort Collins, Colorado, United States, 80524
- Recruiting
- Poudre Valley Hospital
-
Contact:
- Site Public Contact
- Phone Number: 970-297-6150
-
Principal Investigator:
- Linda S. Cook
-
Fort Collins, Colorado, United States, 80528
- Recruiting
- Cancer Care and Hematology-Fort Collins
-
Contact:
- Site Public Contact
- Phone Number: 888-823-5923
- Email: ctsucontact@westat.com
-
Principal Investigator:
- Linda S. Cook
-
Greeley, Colorado, United States, 80631
- Recruiting
- UCHealth Greeley Hospital
-
Contact:
- Site Public Contact
- Phone Number: 888-823-5923
- Email: ctsucontact@westat.com
-
Principal Investigator:
- Linda S. Cook
-
Lafayette, Colorado, United States, 80026
- Recruiting
- Kaiser Permanente-Rock Creek
-
Principal Investigator:
- Debra P. Ritzwoller
-
Contact:
- Site Public Contact
- Phone Number: 303-817-9295
- Email: KPCOIHRClinicalResearch@kp.org
-
Lone Tree, Colorado, United States, 80124
- Recruiting
- Kaiser Permanente-Lone Tree
-
Principal Investigator:
- Debra P. Ritzwoller
-
Contact:
- Site Public Contact
- Phone Number: 303-817-9295
- Email: KPCOIHRClinicalResearch@kp.org
-
Loveland, Colorado, United States, 80538
- Recruiting
- Medical Center of the Rockies
-
Contact:
- Site Public Contact
- Phone Number: 970-203-7083
-
Principal Investigator:
- Linda S. Cook
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96819
- Recruiting
- Kaiser Permanente Moanalua Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 808-432-5195
- Email: shelley.a.clark@kp.org
-
Principal Investigator:
- Stacey Honda
-
-
Michigan
-
Brownstown, Michigan, United States, 48183
- Recruiting
- Henry Ford Cancer Institute-Downriver
-
Contact:
- Site Public Contact
- Phone Number: 313-916-3721
- Email: CTOResearch@hfhs.org
-
Principal Investigator:
- Christine Neslund-Dudas
-
Brownstown, Michigan, United States, 48183
- Recruiting
- Henry Ford Health Center - Brownstown
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Phone Number: 313-874-5472
- Email: CDUDAS1@hfhs.org
-
Chesterfield, Michigan, United States, 48047
- Recruiting
- Henry Ford Health Center - Chesterfield
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Phone Number: 313-874-5472
- Email: CDUDAS1@hfhs.org
-
Clinton Township, Michigan, United States, 48038
- Recruiting
- Henry Ford Macomb Hospital-Clinton Township
-
Contact:
- Site Public Contact
- Phone Number: 313-916-3721
- Email: CTOResearch@hfhs.org
-
Principal Investigator:
- Christine Neslund-Dudas
-
Dearborn, Michigan, United States, 48126
- Recruiting
- Henry Ford Medical Center-Fairlane
-
Contact:
- Site Public Contact
- Phone Number: 313-916-3721
- Email: CTOResearch@hfhs.org
-
Principal Investigator:
- Christine Neslund-Dudas
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
-
Contact:
- Site Public Contact
- Phone Number: 313-916-3721
- Email: CTOResearch@hfhs.org
-
Principal Investigator:
- Christine Neslund-Dudas
-
Detroit, Michigan, United States, 48235
- Recruiting
- Henry Ford Medical Center - Detroit Northwest
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Email: kkeenan1@hfhs.org
-
Grosse Pointe Farms, Michigan, United States, 48236
- Recruiting
- Henry Ford Medical Center-Cottage
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Phone Number: 313-916-1784
-
Livonia, Michigan, United States, 48150
- Recruiting
- Henry Ford Medical Center - Livonia
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Email: kkeenan1@hfhs.org
-
Novi, Michigan, United States, 48377
- Recruiting
- Henry Ford Medical Center-Columbus
-
Contact:
- Site Public Contact
- Phone Number: 313-916-3721
- Email: CTOResearch@hfhs.org
-
Principal Investigator:
- Christine Neslund-Dudas
-
Plymouth, Michigan, United States, 48170
- Recruiting
- Henry Ford Medical Center - Plymouth
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Email: kkeenan1@hfhs.org
-
Royal Oak, Michigan, United States, 48067
- Recruiting
- Henry Ford Medical Center - Royal Oak
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Email: kkeenan1@hfhs.org
-
Sterling Heights, Michigan, United States, 48310
- Recruiting
- Henry Ford Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 888-823-5923
- Email: ctsucontact@westat.com
-
Principal Investigator:
- Christine Neslund-Dudas
-
Troy, Michigan, United States, 48083
- Recruiting
- Henry Ford Medical Center - Troy
-
Principal Investigator:
- Christine Neslund-Dudas
-
Contact:
- Site Public Contact
- Email: kkeenan1@hfhs.org
-
West Bloomfield, Michigan, United States, 48322
- Recruiting
- Henry Ford West Bloomfield Hospital
-
Contact:
- Site Public Contact
- Phone Number: 313-916-3721
- Email: CTOResearch@hfhs.org
-
Principal Investigator:
- Christine Neslund-Dudas
-
Wyandotte, Michigan, United States, 48192
- Recruiting
- Henry Ford Wyandotte Hospital
-
Contact:
- Site Public Contact
- Email: nhay@hfhs.org
-
Principal Investigator:
- Christine Neslund-Dudas
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Recruiting
- Saint Luke's Hospital of Kansas City
-
Contact:
- Site Public Contact
- Phone Number: 913-948-5588
- Email: aroland@kccop.org
-
Principal Investigator:
- Timothy J. Pluard
-
St Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Aimee S. James
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-668-0683
- Email: cancerclinicaltrials@med.unc.edu
-
Principal Investigator:
- Daniel S. Reuland
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Mark Doescher
-
-
Virginia
-
Charlottesville, Virginia, United States, 22911
- Recruiting
- Sentara Martha Jefferson Hospital
-
Contact:
- Site Public Contact
- Phone Number: 434-654-8400
-
Principal Investigator:
- John M. Sayles
-
Fairfax, Virginia, United States, 22031
- Recruiting
- Inova Schar Cancer Institute
-
Principal Investigator:
- Rebecca D. Kaltman
-
Contact:
- Site Public Contact
- Phone Number: 703-720-5210
- Email: Stephanie.VanBebber@inova.org
-
Fairfax, Virginia, United States, 22033
- Recruiting
- Inova Fair Oaks Hospital
-
Principal Investigator:
- Rebecca D. Kaltman
-
Contact:
- Site Public Contact
- Phone Number: 703-720-5210
- Email: Stephanie.VanBebber@inova.org
-
Norfolk, Virginia, United States, 23507
- Recruiting
- Sentara Norfolk General Hospital
-
Contact:
- Site Public Contact
- Phone Number: 757-388-2406
-
Principal Investigator:
- John M. Sayles
-
Richmond, Virginia, United States, 23235
- Recruiting
- VCU Massey Cancer Center at Stony Point
-
Contact:
- Site Public Contact
- Email: ctoclinops@vcu.edu
-
Principal Investigator:
- Alexander H. Krist
-
Richmond, Virginia, United States, 23298
- Recruiting
- VCU Massey Comprehensive Cancer Center
-
Principal Investigator:
- Alexander H. Krist
-
Contact:
- Site Public Contact
- Phone Number: 804-628-6430
- Email: CTOclinops@vcu.edu
-
South Hill, Virginia, United States, 23970
- Recruiting
- VCU Community Memorial Health Center
-
Contact:
- Site Public Contact
- Email: nemer.elmouallem@vcuhealth.org
-
Principal Investigator:
- Alexander H. Krist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 45-75 years old
- Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment
- Agree to allow collection of information from their medical records for study-related purposes
Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic
- Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion
Exclusion Criteria:
Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years
- Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible
- Ongoing cancer diagnostic work-up
- Ongoing participation in another study of an investigational cancer screening test or technology
- Currently breastfeeding or pregnant, or planning to become pregnant in the next year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm III (Control)
Participants undergo blood collection at enrollment and after one year on study.
|
Undergo blood collection
Other Names:
Obtain health data
Study specific questionnaires
|
|
Experimental: Arm I (Shield MCD test)
Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study.
Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing.
Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
|
Undergo blood collection
Other Names:
Undergo Shield MCD test
Other Names:
Undergo Avantect MCD test
Other Names:
Evaluation of MCD tests
Other Names:
Obtain health data
Study specific questionnaires
|
|
Experimental: Arm II (Avantect MCD test)
Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study.
Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing.
Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
|
Undergo blood collection
Other Names:
Undergo Shield MCD test
Other Names:
Undergo Avantect MCD test
Other Names:
Evaluation of MCD tests
Other Names:
Obtain health data
Study specific questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of enrollment onto study
Time Frame: At time of randomization
|
The number of participants enrolled into the study compared to trial goals.
|
At time of randomization
|
|
Proportion of participants who complete baseline and follow-up questionnaires within 60 days of receipt
Time Frame: Up to 3 years
|
The proportion of participants who are complete questionnaires and timing of completion.
|
Up to 3 years
|
|
Proportion of participants who provide the required blood sample for year 1 for Multi-Cancer Detection (MCD) testing within 90 days of recommended time point
Time Frame: Up to 2 years
|
The proportion of participants who have a second blood draw and the timing of the blood draw.
|
Up to 2 years
|
|
Proportion of participants considered lost to follow-up within 2 years of randomization
Time Frame: Up to 2 years
|
The proportion of participants who do not complete study procedures and are not able to be contacted.
|
Up to 2 years
|
|
Representative enrollment
Time Frame: Up to 2 years
|
Meeting or exceeding the trial enrollment goals on a population basis.
|
Up to 2 years
|
|
Staggered start of intervention arm 2
Time Frame: Up to 1 year
|
Advantages and challenges arising from trial activation with one intervention arm and later addition of a second intervention arm.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of participant blinding
Time Frame: Up to 2 years
|
Comparisons between blinded and unblinded sites on participation rates, adherence to protocol-required questionnaires and blood collection, and participation in standard of care screening.
|
Up to 2 years
|
|
Timely return of MCD test result
Time Frame: Up to 2 years
|
The time from receipt of the MCD test result at the Statistics and Data Management Center to the time of receipt of the MCD test result at the ACCESS Hub.
The time from receipt of MCD test result at the ACCESS Hub to the time of participant receipt of the MCD test result.
|
Up to 2 years
|
|
Factors contributing to lack of diagnostic resolution of an abnormal MCD test
Time Frame: Up to 2 years
|
Factors that contribute to the inability to determine if a participant has a cancer or rule out cancer.
|
Up to 2 years
|
|
Contamination
Time Frame: Up to 3 years
|
Estimated as the number of participants receiving MCD testing outside the trial.
|
Up to 3 years
|
|
Effects of participant characteristics
Time Frame: Up to 2 years
|
Feasibility outcomes will be reported by participant demographics and cancer risk factors.
|
Up to 2 years
|
|
Diagnostic resolution following an abnormal MCD test result
Time Frame: Within 12 months following an abnormal MCD test result
|
The proportion of participants with a "cancer diagnosis" or "no cancer diagnosis" among all participants with an abnormal MCD test result
|
Within 12 months following an abnormal MCD test result
|
|
Time to diagnostic resolution
Time Frame: Up to 2 years
|
The number of days from date of ACCESS Hub receipt of abnormal MCD test result to date of provider-reported diagnostic resolution.
|
Up to 2 years
|
|
Participation in standard of care screening
Time Frame: Up to 2 years
|
The proportion of participants that receive standard of care cancer screening in each arm.
|
Up to 2 years
|
|
Accuracy of tissue of origin prediction
Time Frame: Up to 2 years
|
The proportion of diagnosed cancers that match the tissue of origin predicted by an abnormal (positive) MCD test, for each screening episode.
|
Up to 2 years
|
|
Complications related to diagnostic evaluation of an abnormal MCD test result
Time Frame: Up to 1 year
|
Adverse events occurring in participants undergoing a diagnostic workup following receipt of an abnormal MCD test result.
|
Up to 1 year
|
|
Anxiety and Cancer Worry Questionnaire
Time Frame: Up to 2 years
|
Participant anxiety will be assessed with the Patient Reported Outcomes Measurement Information System instrument.
Cancer-related worry will be assessed using the Lehrman Cancer Worry Scale.
|
Up to 2 years
|
|
Sensitivity of clinical diagnostic performance of each MCD assay
Time Frame: Up to 2 years
|
Sensitivity will be estimated for each MCD assay.
These sensitivities will also be calculated by early- versus late-stage, and for MCD test-targeted cancers and all cancers.
|
Up to 2 years
|
|
Specificity of each MCD assay
Time Frame: 1 year
|
Specificity will be estimated for each MCD assay.
|
1 year
|
|
Test positive rates
Time Frame: Up to 2 years
|
The proportion of abnormal MCD tests at each screening episode, and the proportion of participants with at least one abnormal test.
|
Up to 2 years
|
|
False positives
Time Frame: Up to 2 years
|
The number of participants with an abnormal MCD test and no cancer diagnosis.
|
Up to 2 years
|
|
(Targeted cancer) Positive predictive value (PPV)
Time Frame: Up to 2 years
|
The proportion of abnormal MCD tests that result in diagnosis of one of the MCD test-targeted cancers among participants with at least one abnormal test, for each screening episode.
|
Up to 2 years
|
|
(All cancer) PPV
Time Frame: Up to 2 years
|
The proportion of abnormal MCD tests that result in diagnosis of any cancer among participants with at least one abnormal test, for each screening episode.
|
Up to 2 years
|
|
Interval cancers
Time Frame: 1 year
|
The number of MCD test-targeted cancer cases diagnosed within 12 months of a normal MCD test result among participants who received an MCD test, for each screening episode.
|
1 year
|
|
Detected cancers
Time Frame: 1 year
|
The number of cancer cases diagnosed within a 12-month follow-up period of an abnormal test result among participants who received an MCD test, for each screening episode.
|
1 year
|
|
(Targeted cancer) Negative predictive value
Time Frame: 1 year
|
The proportion of normal MCD tests that did not result in diagnosis of one of the MCD test-targeted cancers among participants with a normal test, for each screening episode.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cancer stage
Time Frame: Up to 12 years
|
The stage that a cancer was diagnosed (Surveillance, Epidemiology, and End Results [SEER]).
|
Up to 12 years
|
|
Early and late stages cancer diagnosis
Time Frame: Up to 12 years
|
Counts of early and late-stage cancers by arm, separately for each cancer type.
Early stage is defined as in situ or localized (SEER).
Late stage is defined as regional or distant stage (SEER).
|
Up to 12 years
|
|
Targeted cancer-specific mortality of each MCD assay
Time Frame: Up to 12 years
|
The fraction of MCD-targeted cancers diagnosed during trial participation that resulted in death.
|
Up to 12 years
|
|
Cancer-specific mortality
Time Frame: Up to 12 years
|
The fraction of all cancers diagnosed during trial participation that resulted in death.
|
Up to 12 years
|
|
All-cause mortality
Time Frame: Up to 12 years
|
The probability of participant death by any cause during trial participation, by arm.
|
Up to 12 years
|
|
Estimated costs associated with MCD testing minus estimated costs associated with standard of care screening
Time Frame: Up to 12 years
|
Will estimate average screening costs associated with MCD testing, evaluation of abnormal MCD tests, standard of care screening and evaluation of abnormal standard of care screening results (all MCD arm participants are encouraged to receive standard of care screening), plus cancer site and stage specific treatment costs sourced from the published literature.
|
Up to 12 years
|
|
Participant out of pocket costs
Time Frame: Up to 2 years
|
Portions of direct medical care costs paid directly by participants (e.g., copays, deductibles and uncovered medical bills) and direct non-medical participant costs; for example, transportation costs, travel time and distance, accommodation costs, childcare or elder-care costs will be elicited through an adapted version of the Costs for Patients Questionnaire.
|
Up to 2 years
|
|
Participant work loss
Time Frame: Up to 2 years
|
Participant and caregiver time spent away from work will be estimated using an adapted version of the Productivity Cost Questionnaire.
The dollar value of hours recorded for participant work loss and caregiver time will be estimated using wages from the Bureau of Labor Statistics.
|
Up to 2 years
|
|
Proportion of participants who complete the Military Exposure Questionnaire
Time Frame: At baseline
|
Will evaluate the proportion of participants who complete the Military Exposure Questionnaire, among those who reported military service.
|
At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott D Ramsey, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Genital Diseases, Female
- Lung Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Pancreatic Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Liver Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Esophageal Diseases
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Skin Diseases
- Breast Diseases
- Urologic Neoplasms
- Carcinoma
- Urinary Bladder Diseases
- Skin and Connective Tissue Diseases
- Prostatic Neoplasms
- Stomach Neoplasms
- Carcinoma, Hepatocellular
- Lung Neoplasms
- Colorectal Neoplasms
- Esophageal Neoplasms
- Ovarian Neoplasms
- Breast Neoplasms
- Pancreatic Neoplasms
- Urinary Bladder Neoplasms
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Specimen Handling
Other Study ID Numbers
- NCI-2024-10793 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA015704 (U.S. NIH Grant/Contract)
- CSRN1 (Other Identifier: CTEP)
- UG1CA286954 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ronald LevyBristol-Myers SquibbCompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Extracranial Solid NeoplasmUnited States
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National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Unresectable Solid NeoplasmUnited States, Canada
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University of California, San FranciscoCompletedIntegrative Palliative Care/Psycho-Oncology Telehealth Intervention in Patients With Advanced CancerAdvanced Malignant Solid Neoplasm | Locally Advanced Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
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M.D. Anderson Cancer CenterTerminatedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid NeoplasmUnited States
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National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid NeoplasmUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Refractory NeoplasmUnited States
Clinical Trials on Biospecimen Collection
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Ohio State University Comprehensive Cancer CenterGuardant Health, Inc.CompletedColorectal CarcinomaUnited States
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Assistance Publique - Hôpitaux de ParisNot yet recruiting
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Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)RecruitingCancerUnited States
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CorEvitasEnrolling by invitation
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institute of General Medical Sciences...Active, not recruiting
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M.D. Anderson Cancer CenterActive, not recruitingMetastatic Rectal Adenocarcinoma | Stage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC... and other conditionsUnited States
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Thomas Jefferson UniversityCompletedMalignant Solid Neoplasm | GlioblastomaUnited States
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Matthew Milowsky, MDHoosier Cancer Research Network; Bladder Cancer Advocacy Network (BCAN®)CompletedBladder Cancer | Urothelial Carcinoma | Urethral Cancer | Cancer of the UreterUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8United States
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M.D. Anderson Cancer CenterRecruitingCholangiocarcinoma | Malignant Digestive System NeoplasmUnited States