Colorectal SurgeryBAC-UPP 2NCT07219160
Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery
An observational study of Colorectal Surgery, run by University of Alabama at Birmingham.
Trial summary
Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Colorectal Surgery
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Aug 2030
- Phase
- Observational
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo colorectal surgery
Who may be able to join
- Participants scheduled for colorectal cancer surgery
- Age between 18-65; 3)
- Understanding verbal and written English
Who cannot join
- Concurrent medical conditions that could confound the interpretation of the data
- Human immunodeficiency virus positive diagnosis
- Cardiovascular or pulmonary disease
- Systemic rheumatoid disease
- Uncontrolled hypertension (i.e. SBP/DBP of > 150/95
- Current illness accompanied by fever (body temperature >38 °C)
Show all 14Show fewer
- Any other chronic pain conditions
- Conditions resulting in altered nerve sensation
- Hospitalization due to psychiatric illness within the last 6 months
- Poorly controlled diabetes
- History of stroke
- History of seizures
- Circulatory disorders such AS Raynauds' disease
- History of drug or alcohol abuse.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery (BAC-UPP 2 Study)
Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal surgery and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims:
- The investigators will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery.
- The investigators will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases.
- The investigators will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery.
- The investigators will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.
Read the detailed description
The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following colorectal surgery. Using a biopsychosocial framework, the investigators aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following colorectal surgery. Using a biopsychosocial framework, the investigators aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, the investigators will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
Aim 2: Examine biological and inflammatory mechanisms underlying postoperative pain persistence.
Peripheral blood samples will be collected at multiple time points before and after surgery to quantify circulating markers of inflammation (e.g., IL-6, CRP), neuroendocrine function (e.g., oxytocin, vasopressin), and immune regulation. These biomarkers will be analyzed in relation to clinical pain outcomes to identify biological signatures associated with resilience versus vulnerability to chronic pain. This aim will provide mechanistic insight into how systemic physiological responses to surgery contribute to prolonged nociceptive signaling.
Aim 3: Assess psychosocial determinants of pain and recovery.
The investigators will evaluate key psychological and social-contextual variables, including emotional health, coping style, catastrophizing, optimism, perceived stress, and socioeconomic indicators-to determine how these factors influence postoperative pain experiences and recovery. This comprehensive assessment will clarify how psychological resilience and environmental stressors interact with biological processes to shape individual pain outcomes.
Aim 4: Develop a multidimensional risk model integrating demographic, clinical, and mechanistic predictors.
Using routinely collected demographic and perioperative data (e.g., age, sex, race, comorbidities, analgesic use, surgical approach), combined with the experimental, biological, and psychosocial measures from Aims 1-3, the investigators will construct an integrative predictive model of postoperative pain outcomes. This approach will allow us to identify distinct risk phenotypes and generate clinically actionable profiles for early identification of patients most likely to benefit from personalized perioperative pain management strategies.
Together, these efforts will advance our understanding of how biological, psychological, and contextual factors jointly influence pain recovery after surgery, with the long-term goal of informing precision pain medicine and improving postoperative care. The investigators will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
Aim 2: Examine biological and inflammatory mechanisms underlying postoperative pain persistence.
Peripheral blood samples will be collected at multiple time points before and after surgery to quantify circulating markers of inflammation (e.g., IL-6, CRP), neuroendocrine function (e.g., oxytocin, vasopressin), and immune regulation. These biomarkers will be analyzed in relation to clinical pain outcomes to identify biological signatures associated with resilience versus vulnerability to chronic pain. This aim will provide mechanistic insight into how systemic physiological responses to surgery contribute to prolonged nociceptive signaling.
Aim 3: Assess psychosocial determinants of pain and recovery.
The investigators will evaluate key psychological and social-contextual variables, including emotional health, coping style, catastrophizing, optimism, perceived stress, and socioeconomic indicators-to determine how these factors influence postoperative pain experiences and recovery. This comprehensive assessment will clarify how psychological resilience and environmental stressors interact with biological processes to shape individual pain outcomes.
Aim 4: Develop a multidimensional risk model integrating demographic, clinical, and mechanistic predictors.
Using routinely collected demographic and perioperative data (e.g., age, sex, race, comorbidities, analgesic use, surgical approach), combined with the experimental, biological, and psychosocial measures from Aims 1-3, the investigators will construct an integrative predictive model of postoperative pain outcomes. This approach will allow us to identify distinct risk phenotypes and generate clinically actionable profiles for early identification of patients most likely to benefit from personalized perioperative pain management strategies.
Together, these efforts will advance our understanding of how biological, psychological, and contextual factors jointly influence pain recovery after surgery, with the long-term goal of informing precision pain medicine and improving postoperative care.
- Conditions
- Colorectal Surgery
- Keywords
- colorectal surgery, nociception, acute pain, chronic pain
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Surgery Patients | Patients undergoing colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Pain after colorectal surgery
Pain Measured 3 months following colorectal surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.
Measured: 12 weeks after surgery
Acute Pain after Surgery
Pain rating 48 hours after surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Demario Overstreet, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219160
- Sponsor's protocol ID
- IRB-300015205
- Other IDs
- 1R35GM159908-01
- Acronym
- BAC-UPP 2
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified QST data, biomarkers, survey responses, demographics
Publications
Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
PubMed 26526062Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.
PubMed 19402781Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477.
PubMed 31903595Dobson GP. Trauma of major surgery: A global problem that is not going away. Int J Surg. 2020 Sep;81:47-54. doi: 10.1016/j.ijsu.2020.07.017. Epub 2020 Jul 29.
PubMed 32738546Horn R, Hendrix JM, Kramer J. Postoperative Pain Control. 2024 Jan 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK544298/
PubMed 31335018Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
PubMed 29026331Overstreet DS, Hollis RH. Achieving Health Equity: Advancing Colorectal Surgery among Racial and Ethnic Minorities in America. Clin Colon Rectal Surg. 2024 May 13;38(1):34-40. doi: 10.1055/s-0044-1786532. eCollection 2025 Jan.
PubMed 39734714Overstreet DS, Strath LJ, Sorge RE, Thomas PA, He J, Wiggins AM, Hobson J, Long DL, Meints SM, Aroke EN, Goodin BR. Race-specific associations: inflammatory mediators and chronic low back pain. Pain. 2024 Jul 1;165(7):1513-1522. doi: 10.1097/j.pain.0000000000003154. Epub 2024 Feb 6.
PubMed 38323608
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery (BAC-UPP 2 Study)
- ClinicalTrials.gov ID
- NCT07219160
- Acronym / sponsor ID
- BAC-UPP 2 / IRB-300015205
- Conditions
- Colorectal Surgery
- Keywords
- colorectal surgery, nociception, acute pain, chronic pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 21 Oct 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.
Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal surgery and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims:
- The investigators will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery.
- The investigators will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases.
- The investigators will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery.
- The investigators will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.
Detailed description
The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following colorectal surgery. Using a biopsychosocial framework, the investigators aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, The overarching goal of this study is to elucidate the biological, psychological, and clinical factors that are responsible for pain trajectories following colorectal surgery. Using a biopsychosocial framework, the investigators aim to identify modifiable risk and protective mechanisms that could inform the development of targeted interventions to prevent chronic postsurgical pain.
Aim 1: Characterize individual differences in pain processing using standardized experimental pain testing.
Participants will complete a battery of quantitative sensory testing (QST) measures preoperatively to assess their sensitivity to mechanical, thermal, and pressure-based stimuli. These standardized tests capture individual differences in nociceptive and central pain modulation. By linking preoperative pain sensitivity profiles to postoperative pain intensity and duration, the investigators will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
Aim 2: Examine biological and inflammatory mechanisms underlying postoperative pain persistence.
Peripheral blood samples will be collected at multiple time points before and after surgery to quantify circulating markers of inflammation (e.g., IL-6, CRP), neuroendocrine function (e.g., oxytocin, vasopressin), and immune regulation. These biomarkers will be analyzed in relation to clinical pain outcomes to identify biological signatures associated with resilience versus vulnerability to chronic pain. This aim will provide mechanistic insight into how systemic physiological responses to surgery contribute to prolonged nociceptive signaling.
Aim 3: Assess psychosocial determinants of pain and recovery.
The investigators will evaluate key psychological and social-contextual variables, including emotional health, coping style, catastrophizing, optimism, perceived stress, and socioeconomic indicators-to determine how these factors influence postoperative pain experiences and recovery. This comprehensive assessment will clarify how psychological resilience and environmental stressors interact with biological processes to shape individual pain outcomes.
Aim 4: Develop a multidimensional risk model integrating demographic, clinical, and mechanistic predictors.
Using routinely collected demographic and perioperative data (e.g., age, sex, race, comorbidities, analgesic use, surgical approach), combined with the experimental, biological, and psychosocial measures from Aims 1-3, the investigators will construct an integrative predictive model of postoperative pain outcomes. This approach will allow us to identify distinct risk phenotypes and generate clinically actionable profiles for early identification of patients most likely to benefit from personalized perioperative pain management strategies.
Together, these efforts will advance our understanding of how biological, psychological, and contextual factors jointly influence pain recovery after surgery, with the long-term goal of informing precision pain medicine and improving postoperative care. The investigators will determine whether QST-derived measures can serve as early predictors of maladaptive pain trajectories.
Aim 2: Examine biological and inflammatory mechanisms underlying postoperative pain persistence.
Peripheral blood samples will be collected at multiple time points before and after surgery to quantify circulating markers of inflammation (e.g., IL-6, CRP), neuroendocrine function (e.g., oxytocin, vasopressin), and immune regulation. These biomarkers will be analyzed in relation to clinical pain outcomes to identify biological signatures associated with resilience versus vulnerability to chronic pain. This aim will provide mechanistic insight into how systemic physiological responses to surgery contribute to prolonged nociceptive signaling.
Aim 3: Assess psychosocial determinants of pain and recovery.
The investigators will evaluate key psychological and social-contextual variables, including emotional health, coping style, catastrophizing, optimism, perceived stress, and socioeconomic indicators-to determine how these factors influence postoperative pain experiences and recovery. This comprehensive assessment will clarify how psychological resilience and environmental stressors interact with biological processes to shape individual pain outcomes.
Aim 4: Develop a multidimensional risk model integrating demographic, clinical, and mechanistic predictors.
Using routinely collected demographic and perioperative data (e.g., age, sex, race, comorbidities, analgesic use, surgical approach), combined with the experimental, biological, and psychosocial measures from Aims 1-3, the investigators will construct an integrative predictive model of postoperative pain outcomes. This approach will allow us to identify distinct risk phenotypes and generate clinically actionable profiles for early identification of patients most likely to benefit from personalized perioperative pain management strategies.
Together, these efforts will advance our understanding of how biological, psychological, and contextual factors jointly influence pain recovery after surgery, with the long-term goal of informing precision pain medicine and improving postoperative care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Surgery Patients | – | –Patients undergoing colorectal surgery |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo colorectal surgery
Key inclusion criteria (3 listed)
- Participants scheduled for colorectal cancer surgery
- Age between 18-65; 3)
- Understanding verbal and written English
Key exclusion criteria (14 listed)
- Concurrent medical conditions that could confound the interpretation of the data
- Human immunodeficiency virus positive diagnosis
- Cardiovascular or pulmonary disease
- Systemic rheumatoid disease
- Uncontrolled hypertension (i.e. SBP/DBP of > 150/95
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic Pain after colorectal surgery
Time frame: 12 weeks after surgery
Pain Measured 3 months following colorectal surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.
Acute Pain after Surgery
Time frame: 48 hours after surgery
Pain rating 48 hours after surgery using the Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. Change scores will be calculated.
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 13 Jul 2026.
- Background: PubMed 26526062Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
- Background: PubMed 19402781Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.
- Background: PubMed 31903595Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477.
- Background: PubMed 32738546Dobson GP. Trauma of major surgery: A global problem that is not going away. Int J Surg. 2020 Sep;81:47-54. doi: 10.1016/j.ijsu.2020.07.017. Epub 2020 Jul 29.
- Background: PubMed 31335018Horn R, Hendrix JM, Kramer J. Postoperative Pain Control. 2024 Jan 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK544298/
- Background: PubMed 29026331Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Background: PubMed 39734714Overstreet DS, Hollis RH. Achieving Health Equity: Advancing Colorectal Surgery among Racial and Ethnic Minorities in America. Clin Colon Rectal Surg. 2024 May 13;38(1):34-40. doi: 10.1055/s-0044-1786532. eCollection 2025 Jan.
- Background: PubMed 38323608Overstreet DS, Strath LJ, Sorge RE, Thomas PA, He J, Wiggins AM, Hobson J, Long DL, Meints SM, Aroke EN, Goodin BR. Race-specific associations: inflammatory mediators and chronic low back pain. Pain. 2024 Jul 1;165(7):1513-1522. doi: 10.1097/j.pain.0000000000003154. Epub 2024 Feb 6.
- Individual participant dataSharing planned: Yes. de-identified QST data, biomarkers, survey responses, demographics
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery, run by University of Alabama at Birmingham.
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 3 inclusion and 14 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Demario S Overstreet, Ph.D. (13344130112, demariooverstreet@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pain after colorectal surgery (time frame: 12 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07219160, which also lists 8 linked publications.
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 13 Jul 2026.