Fecal Immunochemical TestNCT07183046
Implementation Intention Planning Guide for FIT Colon Cancer Screening
A study testing Implementation Intention Guide in people with Fecal Immunochemical Test and Colorectal Cancer Screening, run by Dartmouth-Hitchcock Medical Center at 5 sites in United States.
Trial summary
Fecal immunochemical tests (FIT) are a primary method of screening for colorectal cancer (CRC). Implementation intention planning involves encouraging completion or eliminating barriers for the participant to make a plan to complete a behavior or activity. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Immunochemical Test, Colorectal Cancer Screening
- What is being tested?
- Implementation Intention Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-75
- Cared for by primary care at General Internal Medicine Clinic, Dartmouth-Hitchcock Medical Center (Lebanon, NH), Dartmouth Hitchcock Clinics Heater Road Primary Care (Lebanon, NH), Dartmouth Hitchcock Clinics Lyme Primary Care (Lyme, NH), or White River Junction Veterans Affairs Medical Center (White River Junction, VT) OR eligible for FIT through VA Mailed FIT Program
Who cannot join
- none
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Timothy McAuliffe, BA contact
5 sites in 1 country
United States5 sites
Dartmouth Hitchcock Clinics, Heater Road Primary Care
Lebanon, New Hampshire, 03766
Audrey H Calderwood, MD, MS, Audrey.H.Calderwood@hitchcock.org
Dartmouth-Hitchcock Medical Center, General Internal Medicine Clinic
Lebanon, New Hampshire, 03766
Audrey H Calderwood, MD, MS, Audrey.H.Calderwood@hitchcock.org
Dartmouth Hitchcock Clinics, Lyme Primary Care Clinic
Lyme, New Hampshire, 03768
Audrey H Calderwood, MD, MS, Audrey.H.Calderwood@hitchcock.org
White River Junction Veterans Affairs Medical Center, Primary Care Clinic
White River Junction, Vermont, 05009
Douglas Robertson, MD, MPH, douglas.robertson@va.gov
White River Junction Veterans Affairs Medical Center, VA Mailed FIT Program
White River Junction, Vermont, 05009
Douglas Robertson, MD, MPH, douglas.robertson@va.gov
About this study
Official title: Impact of an Implementation Intention Planning Guide on Fecal Immunochemical Tests (FIT) Completion Rates
Fecal immunochemical tests (FIT) are a primary method of screening for colorectal cancer (CRC). Implementation intention planning involves encouraging completion or eliminating barriers for the participant to make a plan to complete a behavior or activity. This randomized control study seeks to answer whether the addition of an implementation intention guide impacts behaviors when completing FIT screening. The primary objective includes determining if the implementation intention guide increases completion rate of screening FIT. The secondary objectives is whether this intervention decreases the lab sample rejection rate and reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.
Read the detailed description
Colorectal cancer (CRC) has a high incidence, burden of disease, and significant associated mortality.(1,2) Programs to screen for CRC have leveraged stool testing with the fecal immunochemical test (FIT), a non-invasive at home test with no inherent risks, as the primary method in many countries.(3) Advantages of screening with FIT include considerations of safety, simplicity, and cost. However, while this and other options are available for colorectal cancer screening, patient screening rates have still not achieved recommended 70-80% targets.(4) In order to increase colorectal cancer screening rates, various behavioral interventions (including screening reminders, mailed screening outreach, choice architecture) have been implemented with success.(5,6)
Implementation intention planning involves encouraging or eliminating barriers for the participant to make a plan and complete FIT. Prior examples found that touchscreen implementation intention planning increased CRC screening completion by 12%.(7) For FOBT specifically, implementation intention planning instructions increased completion by 1.2-6.6%.(8) However, pre-written tips about FIT related to barriers did not increase FIT completion.(9)
This study seeks to understand the impact of a simple implementation intention planning guide (one-page piece of paper) on increasing rates of successful completion of FIT for colorectal cancer screening. The implementation intention planning guide is a one-page document that encourages the patient to make concrete plans about completing FIT. This study will evaluate if this low-cost intervention improves the rate of successful completion and reduces the duration between sample collection and lab result.
While some versions of implementation intention planning for CRC screening have been evaluated and shown positive impact in CRC screening completion, this study is hoping to build on these findings to evaluate a simplified implementation intention guide for patients specific to FIT. If this intervention is found to improve completion, these significant findings would support future FIT programs with a simple intervention to improve community screening rates. If these interventions do not improve completion, this research will inform the need to pursue investment in evaluating other interventions to improve FIT screening rates.
Aim 1: To determine if inclusion of implementation intention guide in FIT increases 90-day completion rate of screening FIT.
Hypothesis 1: The inclusion of implementation intention guide in FIT will increase the 90-day completion rate of screening FIT by 7%.
Aim 2: To determine if inclusion of implementation intention guide with FIT reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.
Hypothesis 2: The inclusion of implementation intention guide in FIT will reduce the duration between sample collection and laboratory receipt/evaluation by 20% in number of days and increase the number of samples received in the clinically appropriate time window of screening FIT (reducing the sample rejection rate) by 20%.
References:
- Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA: A Cancer Journal for Clinicians. 2023/05// 2023;73(3):233-254. doi:10.3322/caac.21772
- Araghi M, Soerjomataram I, Jenkins M, et al. Global trends in colorectal cancer mortality: projections to the year 2035. https://doi.org/10.1002/ijc.32055. International Journal of Cancer. 2019/06/15 2019;144(12):2992-3000. doi:https://doi.org/10.1002/ijc.32055
- Young GP, Rabeneck L, Winawer SJ. The Global Paradigm Shift in Screening for Colorectal Cancer. Gastroenterology. 2019/03/01/ 2019;156(4):843-851.e2. doi:https://doi.org/10.1053/j.gastro.2019.02.006
- Green BB. Colorectal Cancer Control: Where Have We Been and Where Should We Go Next? JAMA Intern Med. 2018/12/01/ 2018;178(12):1658. doi:10.1001/jamainternmed.2018.4627
- Mehta SJ, Palat S, McDonald C, et al. A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association. 2024/04/30/ 2024:S1542-3565(24)00390-2. doi:10.1016/j.cgh.2024.04.003
- Deeds S, Schuttner L, Wheat C, et al. Automated Reminders Enhance Mailed Fecal Immunochemical Test Completion Among Veterans: a Randomized Controlled Trial. J GEN INTERN MED. 2024/01// 2024;39(1):113-119. doi:10.1007/s11606-023-08409-8
- Greiner KA, Daley CM, Epp A, et al. Implementation Intentions and Colorectal Screening. American Journal of Preventive Medicine. 2014/12// 2014;47(6):703-714. doi:10.1016/j.amepre.2014.08.005
- Neter E, Stein N, Barnett-Griness O, Rennert G, Hagoel L. From the Bench to Public Health. American Journal of Preventive Medicine. 2014/03// 2014;46(3):273-280. doi:10.1016/j.amepre.2013.11.008
- Lo SH, Good A, Sheeran P, et al. Preformulated implementation intentions to promote colorectal cancer screening: A cluster-randomized trial. Health Psychology. 2014 2014;33(9):998-1002. doi:10.1037/a0033507
- Being tested
- Implementation Intention Guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Intention GuideBehavioural
The intervention is the addition of implementation intention guide document provided with the FIT. This is a one-page piece of paper that was developed by the investigator team and finalized with input/feedback from patient partners. The implementation intention guide includes instructions about the importance of developing a plan to complete FIT. It also includes fillable fields for participants to enter their plan for when to complete, where to store, when to return, and where to return their FIT. Participants will also be able to follow a QR code on the implementation intention guide document to a link to complete an anonymous, electronic version of the guide and share feedback on the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (FIT Standard of Care) | No intervention | The Control Arm will receive the fecal immunochemical test (FIT) standard of care. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. Any follow-up materials or communications with their provider will also follow FIT standard of care. They will not receive any additional document/implementation intention guide with their FIT. |
| Intervention Arm (FIT Standard of Care with Implementation Intention Guide) | Experimental | The Intervention Arm will receive the fecal immunochemical test (FIT) standard of care and the implementation intention guide one-page document. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. They will also receive the implementation intention guide being evaluated in this study. Any follow-up materials or communications with their provider will also follow FIT standard of care. Receives: Behavioral: Implementation Intention Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT completion rate
Percentage of participants who have completed, returned, and have received completed lab results for FIT 90 days following participant reception of FIT.
Measured: Through study completion, approximately 12-18 months
Secondary outcomes (2)
Duration between FIT collection date and receipt by the laboratory
Number of days from the participant FIT collection date (as reported by the participant on the FIT collection bottle) to the date the lab received the participant's FIT.
Measured: Through study completion, approximately 12-18 months
Rate of lab sample rejection
Percentage of FIT samples rejected from the lab to not be appropriate for further evaluation (e.g., incorrect sampling/storage, expired test)
Measured: Through study completion, approximately 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Immunochemical TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be grouped into intervention and control groups based on alternating weeks/months when they obtain their FIT throughout the study. These timelines will be designated before the initiation of the study with appropriate frequency of alternation to reduce variability between non-study conditions between the weeks/months.
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- White River Junction Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Audrey H. Calderwood, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183046
- Sponsor's protocol ID
- STUDY02002735
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Implementation Intention Planning Guide on Fecal Immunochemical Tests (FIT) Completion Rates
- ClinicalTrials.gov ID
- NCT07183046
- Acronym / sponsor ID
- STUDY02002735
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- White River Junction Veterans Affairs Medical Center
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fecal immunochemical tests (FIT) are a primary method of screening for colorectal cancer (CRC). Implementation intention planning involves encouraging completion or eliminating barriers for the participant to make a plan to complete a behavior or activity. This randomized control study seeks to answer whether the addition of an implementation intention guide impacts behaviors when completing FIT screening. The primary objective includes determining if the implementation intention guide increases completion rate of screening FIT. The secondary objectives is whether this intervention decreases the lab sample rejection rate and reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.
Detailed description
Colorectal cancer (CRC) has a high incidence, burden of disease, and significant associated mortality.(1,2) Programs to screen for CRC have leveraged stool testing with the fecal immunochemical test (FIT), a non-invasive at home test with no inherent risks, as the primary method in many countries.(3) Advantages of screening with FIT include considerations of safety, simplicity, and cost. However, while this and other options are available for colorectal cancer screening, patient screening rates have still not achieved recommended 70-80% targets.(4) In order to increase colorectal cancer screening rates, various behavioral interventions (including screening reminders, mailed screening outreach, choice architecture) have been implemented with success.(5,6)
Implementation intention planning involves encouraging or eliminating barriers for the participant to make a plan and complete FIT. Prior examples found that touchscreen implementation intention planning increased CRC screening completion by 12%.(7) For FOBT specifically, implementation intention planning instructions increased completion by 1.2-6.6%.(8) However, pre-written tips about FIT related to barriers did not increase FIT completion.(9)
This study seeks to understand the impact of a simple implementation intention planning guide (one-page piece of paper) on increasing rates of successful completion of FIT for colorectal cancer screening. The implementation intention planning guide is a one-page document that encourages the patient to make concrete plans about completing FIT. This study will evaluate if this low-cost intervention improves the rate of successful completion and reduces the duration between sample collection and lab result.
While some versions of implementation intention planning for CRC screening have been evaluated and shown positive impact in CRC screening completion, this study is hoping to build on these findings to evaluate a simplified implementation intention guide for patients specific to FIT. If this intervention is found to improve completion, these significant findings would support future FIT programs with a simple intervention to improve community screening rates. If these interventions do not improve completion, this research will inform the need to pursue investment in evaluating other interventions to improve FIT screening rates.
Aim 1: To determine if inclusion of implementation intention guide in FIT increases 90-day completion rate of screening FIT.
Hypothesis 1: The inclusion of implementation intention guide in FIT will increase the 90-day completion rate of screening FIT by 7%.
Aim 2: To determine if inclusion of implementation intention guide with FIT reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.
Hypothesis 2: The inclusion of implementation intention guide in FIT will reduce the duration between sample collection and laboratory receipt/evaluation by 20% in number of days and increase the number of samples received in the clinically appropriate time window of screening FIT (reducing the sample rejection rate) by 20%.
References:
- Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA: A Cancer Journal for Clinicians. 2023/05// 2023;73(3):233-254. doi:10.3322/caac.21772
- Araghi M, Soerjomataram I, Jenkins M, et al. Global trends in colorectal cancer mortality: projections to the year 2035. https://doi.org/10.1002/ijc.32055. International Journal of Cancer. 2019/06/15 2019;144(12):2992-3000. doi:https://doi.org/10.1002/ijc.32055
- Young GP, Rabeneck L, Winawer SJ. The Global Paradigm Shift in Screening for Colorectal Cancer. Gastroenterology. 2019/03/01/ 2019;156(4):843-851.e2. doi:https://doi.org/10.1053/j.gastro.2019.02.006
- Green BB. Colorectal Cancer Control: Where Have We Been and Where Should We Go Next? JAMA Intern Med. 2018/12/01/ 2018;178(12):1658. doi:10.1001/jamainternmed.2018.4627
- Mehta SJ, Palat S, McDonald C, et al. A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association. 2024/04/30/ 2024:S1542-3565(24)00390-2. doi:10.1016/j.cgh.2024.04.003
- Deeds S, Schuttner L, Wheat C, et al. Automated Reminders Enhance Mailed Fecal Immunochemical Test Completion Among Veterans: a Randomized Controlled Trial. J GEN INTERN MED. 2024/01// 2024;39(1):113-119. doi:10.1007/s11606-023-08409-8
- Greiner KA, Daley CM, Epp A, et al. Implementation Intentions and Colorectal Screening. American Journal of Preventive Medicine. 2014/12// 2014;47(6):703-714. doi:10.1016/j.amepre.2014.08.005
- Neter E, Stein N, Barnett-Griness O, Rennert G, Hagoel L. From the Bench to Public Health. American Journal of Preventive Medicine. 2014/03// 2014;46(3):273-280. doi:10.1016/j.amepre.2013.11.008
- Lo SH, Good A, Sheeran P, et al. Preformulated implementation intentions to promote colorectal cancer screening: A cluster-randomized trial. Health Psychology. 2014 2014;33(9):998-1002. doi:10.1037/a0033507
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be grouped into intervention and control groups based on alternating weeks/months when they obtain their FIT throughout the study. These timelines will be designated before the initiation of the study with appropriate frequency of alternation to reduce variability between non-study conditions between the weeks/months.
| Arm | Type | Receives |
|---|---|---|
| Control Arm (FIT Standard of Care) | No intervention | –The Control Arm will receive the fecal immunochemical test (FIT) standard of care. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. Any follow-up materials or communications with their provider will also follow FIT standard of care. They will not receive any additional document/implementation intention guide with their FIT. |
| Intervention Arm (FIT Standard of Care with Implementation Intention Guide) | Experimental | Behavioral: Implementation Intention GuideThe Intervention Arm will receive the fecal immunochemical test (FIT) standard of care and the implementation intention guide one-page document. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. They will also receive the implementation intention guide being evaluated in this study. Any follow-up materials or communications with their provider will also follow FIT standard of care. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 45-75
- Cared for by primary care at General Internal Medicine Clinic, Dartmouth-Hitchcock Medical Center (Lebanon, NH), Dartmouth Hitchcock Clinics Heater Road Primary Care (Lebanon, NH), Dartmouth Hitchcock Clinics Lyme Primary Care (Lyme, NH), or White River Junction Veterans Affairs Medical Center (White River Junction, VT) OR eligible for FIT through VA Mailed FIT Program
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation Intention GuideThe intervention is the addition of implementation intention guide document provided with the FIT. This is a one-page piece of paper that was developed by the investigator team and finalized with input/feedback from patient partners. The implementation intention guide includes instructions about the importance of developing a plan to complete FIT. It also includes fillable fields for participants to enter their plan for when to complete, where to store, when to return, and where to return their FIT. Participants will also be able to follow a QR code on the implementation intention guide document to a link to complete an anonymous, electronic version of the guide and share feedback on the intervention. | Behavioural | Intervention Arm (FIT Standard of Care with Implementation Intention Guide) |
Primary outcome
FIT completion rate
Time frame: Through study completion, approximately 12-18 months
Percentage of participants who have completed, returned, and have received completed lab results for FIT 90 days following participant reception of FIT.
2 secondary outcomes
Duration between FIT collection date and receipt by the laboratory
Time frame: Through study completion, approximately 12-18 months
Rate of lab sample rejection
Time frame: Through study completion, approximately 12-18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Fecal Immunochemical Test
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Recruiting
Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
Colorectal Polyp, Colorectal Neoplasms
Recruiting
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
Adenoma Detection Rate, Colonoscopy
RecruitingPhase 3
EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST. (SUIVICOLO)
Colorectal Cancer Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy McAuliffe, BA contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intention Guide in people with Fecal Immunochemical Test and Colorectal Cancer Screening, run by Dartmouth-Hitchcock Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey H Calderwood, MD, MS (603-650-5261, Audrey.H.Calderwood@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIT completion rate (time frame: Through study completion, approximately 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.