Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors (ROME)

September 12, 2025 updated by: Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)

The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.

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.
Interventional

Enrollment (Estimated)

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.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.
  • Name: Laura Q Rogers, MD, MPH
  • Phone Number: 2059349735 (205) - 934 - 9735
  • Email: rogersl@uab.edu

Study Contact Backup

  • Name: Ildiko Nyikos, M.A., ACSM-RCEP
  • Phone Number: (205) - 975-0002
  • Email: inyikos@uabmc.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-001
        • University of Alabama at Birmingham

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

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
  • ≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
  • Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
  • English speaking,
  • Physician medical clearance for study participation,
  • Able to ambulate without assistance,
  • No antibiotics for the past 90 days,
  • Willing to avoid taking probiotics for the duration of the study
  • Peak VO2 <30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).

Exclusion criteria:

  • Metastatic or recurrent cancer
  • Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3)
  • Unstable angina
  • New York Heart Association class II, III, or IV congestive heart failure
  • Uncontrolled asthma
  • Interstitial lung disease
  • Current steroid use
  • Having been told by a physician to only do exercise prescribed by a physician
  • Dementia or organic brain syndrome
  • Schizophrenia or active psychosis
  • Connective tissue or rheumatologic disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
  • Anticipate elective surgery during the study period
  • Anticipate changes in usual medications during the study period
  • Plan to move residence out of the local area during the study period
  • Plan to travel out of the local area for >1 week during study participation
  • Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
  • Currently pregnant or anticipate pregnancy during study participation
  • Live or work >50 miles from study site or do not have transportation to study site
  • BMI >50
  • Anticipate needing antibiotics during the study period

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Aerobic Exercise Training
Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
Other: Aerobic Exercise Training
Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention.
Active Comparator: Attention Control
The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
Other: Attention Control
The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance.

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
Composition of gut microbiota as measured by fecal samples
Time Frame: Baseline
Using standard diversity and taxa comparison metrics
Baseline
Composition of gut microbiota as measured by fecal samples
Time Frame: 5 weeks after baseline
Using standard diversity and taxa comparison metrics
5 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Time Frame: 10 weeks after baseline
Using standard diversity and taxa comparison metrics
10 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Time Frame: 15 weeks after baseline
Using standard diversity and taxa comparison metrics
15 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systemic inflammation tested via blood biomarkers
Time Frame: Baseline
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
Baseline
Systemic inflammation tested via blood biomarkers
Time Frame: 5 weeks after baseline
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
5 weeks after baseline
Systemic inflammation tested via biomarkers
Time Frame: 10 weeks after baseline
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
10 weeks after baseline
Systemic inflammation tested via blood biomarkers
Time Frame: 15 weeks after baseline
Blood samples will be analyzed for markers of inflammation (IL-6, IL-10)
15 weeks after baseline
Concentration of cortisol measured through hair sample
Time Frame: Baseline
Hormone change that is associated with stress
Baseline
Concentration of cortisol measured through hair sample
Time Frame: 5 weeks after baseline
Hormone change that is associated with stress
5 weeks after baseline
Concentration of cortisol measured through hair sample
Time Frame: 10 weeks after baseline
Hormone change that is associated with stress
10 weeks after baseline
Concentration of cortisol measured through hair sample
Time Frame: 15 weeks after baseline
Hormone change that is associated with stress
15 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time Frame: Baseline
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Baseline
Fatigue measured through fatigue specific questionnaire
Time Frame: 5 weeks after baseline
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
5 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time Frame: 10 weeks after baseline
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
10 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Time Frame: 15 weeks after baseline
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
15 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Time Frame: Baseline
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
Baseline
Autonomic nervous system measured through non-invasive ECG
Time Frame: 5 weeks after baseline
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
5 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Time Frame: 10 weeks after baseline
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
10 weeks after baseline
Autonomic nervous system measured through non-invasive ECG
Time Frame: 15 weeks after baseline
Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly
15 weeks after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Time Frame: Baseline
Cardiorespiratory fitness test on a treadmill
Baseline
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Time Frame: 5 weeks after baseline
Cardiorespiratory fitness test on a treadmill
5 weeks after baseline
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Time Frame: 10 weeks after baseline
Cardiorespiratory fitness test on a treadmill
10 weeks after baseline
Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol
Time Frame: 15 weeks after baseline
Cardiorespiratory fitness test on a treadmill
15 weeks after baseline
Walking Economy measured via 6 minute treadmill test
Time Frame: Baseline
Fitness test on a treadmill
Baseline
Walking Economy measured via 6 minute treadmill test
Time Frame: 5 weeks after baseline
Fitness test on a treadmill
5 weeks after baseline
Walking Economy measured via 6 minute treadmill test
Time Frame: 10 weeks after baseline
Fitness test on a treadmill
10 weeks after baseline
Walking Economy measured via 6 minute treadmill test
Time Frame: 15 weeks after baseline
Fitness test on a treadmill
15 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Time Frame: Baseline
Motion sensor measures physical activity not observed during intervention activities
Baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Time Frame: 5 weeks after baseline
Motion sensor measures physical activity not observed during intervention activities
5 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Time Frame: 10 weeks after baseline
Motion sensor measures physical activity not observed during intervention activities
10 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Time Frame: 15 weeks after baseline
Motion sensor measures physical activity not observed during intervention activities
15 weeks after baseline
Body composition using a dual energy x-ray absorptiometry
Time Frame: Baseline
Measurement of body composition
Baseline
Body composition using a dual energy x-ray absorptiometry
Time Frame: 5 weeks after baseline
Measurement of body composition
5 weeks after baseline
Body composition using a dual energy x-ray absorptiometry
Time Frame: 10 weeks after baseline
Measurement of body composition
10 weeks after baseline
Body composition using a dual energy x-ray absorptiometry
Time Frame: 15 weeks after baseline
Measurement of body composition
15 weeks after baseline
FACT-B self-administered survey measuring quality of life
Time Frame: Baseline
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
Baseline
FACT-B self-administered survey measuring quality of life
Time Frame: 5 weeks after baseline
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
5 weeks after baseline
FACT-B self-administered survey measuring quality of life
Time Frame: 10 weeks after baseline
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
10 weeks after baseline
FACT-B self-administered survey measuring quality of life
Time Frame: 15 weeks after baseline
Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life
15 weeks after baseline
Self-efficacy by self-administered survey
Time Frame: Baseline
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
Baseline
Self-efficacy by self-administered survey
Time Frame: 6 weeks after baseline
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
6 weeks after baseline
Self-efficacy by self-administered survey
Time Frame: 10 weeks after baseline
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
10 weeks after baseline
Self-efficacy by self-administered survey
Time Frame: 15 weeks after baseline
Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy.
15 weeks after baseline
Self-administered survey measuring mood and stress
Time Frame: Baseline
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
Baseline
Self-administered survey measuring mood and stress
Time Frame: 5 weeks after baseline
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
5 weeks after baseline
Self-administered survey measuring mood and stress
Time Frame: 10 weeks after baseline
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
10 weeks after baseline
Self-administered survey measuring mood and stress
Time Frame: 15 weeks after baseline
Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress.
15 weeks after baseline
Self-administered survey measuring memory
Time Frame: Baseline
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
Baseline
Self-administered survey measuring memory
Time Frame: 5 weeks after baseline
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
5 weeks after baseline
Self-administered survey measuring memory
Time Frame: 10 weeks after baseline
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
10 weeks after baseline
Self-administered survey measuring memory
Time Frame: 15 weeks after baseline
Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory.
15 weeks after baseline

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.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

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: Laura Q Rogers, MD, MPH, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 17, 2020

Primary Completion (Actual)

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.
September 5, 2025

Study Completion (Estimated)

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.
August 31, 2026

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).
August 3, 2019

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.
September 10, 2019

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.
September 13, 2019

Study Record Updates

Last Update Posted (Estimated)

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.
September 16, 2025

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.
September 12, 2025

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.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • IRB-30000320
  • R01CA235598 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any data collected with National Institutes of Health (NIH) funding and made public through publication in a peer-reviewed format will thereafter be available on request to faculty of institutions with Public Health Service (PHS) assurance. For sharing data and specimens from individual human subjects, the investigators will comply with all relevant policies including the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). For sharing data, the investigators will comply with the requirements of the Final NIH Statement on Sharing Research Data (NOT-OD-03-032), the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (NOT-OD-07-088), the NIH Genomic Data Sharing Policy (NOT-OD-14-124), and all other existing, updated, and new requirements as stated by NIH policy.

IPD Sharing Time Frame

To be determined

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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