Morehouse Total Cancer Care Protocol (MSMTCC)

March 16, 2021 updated by: James Lillard, PhD, Morehouse School of Medicine

Morehouse Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer

The overall objective of the Morehouse Total Cancer Care study is to develop an improved standard of cancer care by facilitating new biomarker and drug target discovery, informatics solutions, clinical trials, and "personalized medicine" for our community oncology partners (i.e., community hospital systems, and other cancer care providers). To bring new translational research to the community, Morehouse School of Medicine has initiated the Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of African American cancer patients, survivors, or those at risk of having cancer. This is not a treatment trial, but a longitudinal study designed to create a centralized cancer biorepository for precision medicine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Through this protocol, Morehouse School of Medicine and its partners will establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer. In this protocol, investigators require an informed consent of patients to study their answers to survey questions that may be collected as part of their regular clinical care, permission to study their medical and related records, and permission to collect excess tissues removed at the time of planned surgery, an additional tumor sampling (needle passes) at the time of planned diagnostic biopsies, previously collected, stored tumor tissue (if available), blood, and/or other biological samples. Additional research tumor samples may be collected at the time of any diagnostic needle biopsy or endoscopic biopsy or, if available, patient tissue from a previous procedure will be obtained and utilized as needed. Clinical and related data will be collected on all patients from the time of initial entry into the study and will continue for life.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age or older who have cancer or are at risk of developing cancer.

Description

Inclusion Criteria:

  1. 18 years of age and older.
  2. Diagnosed with cancer, or at risk for cancer. This includes anyone in the general population, but our primary focus will be on patients with a cancer diagnosis.
  3. Able to understand and sign the TCCP Informed Consent and Research Authorization form directly or through an authorized representative. The Informed Consent and Research Authorization will be available in both English and Spanish languages

Exclusion Criteria:

None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Biospeciman Repository and Data Collection
Patients with cancer or who are at risk of having cancer who have given consent to have blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected and stored for the advancement of medicine.
Procedure: Collection of blood, tissue, and other biological samples.
Behavioral health assessments, including quality of life.
Other Names:
  • Surveys
Other: Medical Chart Review
Health data abstracted directly from patient's health records

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improve Standard of Cancer Care
Time Frame: Time Frame: up to 20 years
Establish a longitudinal clinical and related data and tissue repository that will contain cancer predisposing risk factors via surveys and questionnaires.
Time Frame: up to 20 years
Improve Standard of Cancer Care
Time Frame: Time Frame: up to 20 years
Establish a longitudinal clinical and related data repository that will contain quality of life care via surveys and questionnaires
Time Frame: up to 20 years
Improve Standard of Cancer Care
Time Frame: Time Frame: up to 20 years
Establish a longitudinal tissue repository that will contain blood, tissue, and other biological samples other biological samples and associated clinical data collected from consenting patients.
Time Frame: up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Morehouse School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James W Lillard, PhD, Morehouse School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2035

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 841718

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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