Colorectal Carcinoma (CRC)NeocolonNCT07422974
Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer
An observational study of Colorectal Carcinoma (CRC) and Complications, run by Osijek University Hospital at 1 site in Croatia.
Trial summary
This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma (CRC), Complications, Neoadjuvant Therapy
- What is being tested?
- Skin and subcutaneous tissue sampling for histopathological analysis and Blood sampling for laboratory analyses before and after surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteCroatia
- Study dates
- 9 Jan 2026to 1 May 2027
- How long will I take part?
- 2 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult patients (≥18 years) with histologically confirmed colorectal cancer who are scheduled for elective surgery, laparoscopic or open. Both sexes will be included in the study. The study population includes patients who received neoadjuvant therapy (study group) and those who did not (control group).
Who may be able to join
- Adults aged ≥18 years with histologically confirmed colorectal cancer
- Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy)
- Ability to understand the study protocol and provide written informed consent.
- Both sexes
- ASA classification II or III
- Patients who received neoadjuvant therapy is investigational group and patients who did not receive neoadjuvant therapy is control group
Who cannot join
- Age <18 years
- Patients who are not conscious, not oriented, or unable to provide informed consent
- Patients unable to understand the study protocol
- Emergency surgical cases
- Patients on chronic corticosteroid therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
KBC Osijek
Osijek, 31000
Slavica Kvolik, Prof.PhD, 0038531511511, slavica.kvolik@gmail.com
About this study
Official title: The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection
This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.
Read the detailed description
The study hypothesis is that neoadjuvant therapy of colorectal cancer leads to endothelial dysfunction, reduced microvascular density, and tissue fibrosis, and therefore contributes to the occurrence of perioperative complications. The primary objective of the study is to assess the association between microvascular density and neoadjuvant therapy, identify differences in biomarkers and demographic factors between patients with neoadjuvant therapy and those without neoadjuvant therapy, and compare clinical outcomes between patients treated with neoadjuvant therapy and those who underwent surgery as initial treatment. Secondary objectives are to determine the association of microvascular density and fibrosis in surgical wound tissue with postoperative complications and wound healing complications, and identify differences in biomarkers between patients with and without perioperative complications.
The study was approved by the Ethics Committee of the Osijek Clinical Hospital Center.
The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy and 34 patients undergoing colorectal cancer surgery who did not receive neoadjuvant therapy but whose first-line treatment is surgery. During the surgery, a skin and subcutaneous tissue sample will be taken for pathohistological analysis of microvascular density and tissue fibrosis, allowing for a more detailed assessment of microvascular changes associated with perioperative complications. It is planned to follow the patient from the surgery until the end of hospitalization, and data on post-discharge complications will be tracked through the medical history in the Hospital Information System one month after discharge from the hospital.
- Being tested
- Skin and subcutaneous tissue sampling for histopathological analysis, Blood sampling for laboratory analyses before and after surgery
- Keywords
- Colorectal Carcinoma, Neoadjuvant Therapy, Microvascular Density, Treatment Outcome, Wound Healing, Critical care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin and subcutaneous tissue sampling for histopathological analysisProcedure or surgery
During the operation, a sample of skin and subcutaneous tissue approximately 1 cm long and 2 mm wide will be taken from the surgical incision site. The sample will be taken from an area that has not previously been affected by radiotherapy and will not compromise patient safety.
Histopathological analysis will be performed in the Clinical Department of Pathology and Forensic Medicine. The degree of fibrosis of the skin and subcutaneous tissue and the microvascular density of the skin tissue will be analyzed using the marker CD31 (PECAM-1).
Blood sampling for laboratory analyses before and after surgeryProcedure or surgery
Before surgery, blood samples will be taken for laboratory analysis. The following parameters will be assessed: leukocytes, hemoglobin, hematocrit, platelets, prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, urea, creatinine, blood glucose, potassium, AST, ALT, GGT, CRP, albumin, cholinesterase, IL-6, von Willebrand factor, and endothelin-1.
Laboratory findings will be monitored 16 hours after surgery (leukocytes, hemoglobin, hematocrit, platelets, PV, fibrinogen, d-dimers, urea, creatinine, GUK, K, CRP, albumin, PCT, cholinesterase, IL-6) and before discharge from the hospital (leukocytes, hemoglobin, hematocrit, platelets, PV, urea, creatinine, GUK, K, CRP, albumin).
Blood sampling will be conducted according to standard clinical protocols, ensuring patient safety and minimal discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received neoadjuvant therapy. | The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy. Receives: Procedure: Skin and subcutaneous tissue sampling for histopathological analysis; Procedure: Blood sampling for laboratory analyses before and after surgery | |
| Patients who did not receive neoadjuvant therapy, control group. | The control group will include 34 patients undergoing colorectal cancer surgery who have not received neoadjuvant therapy. Receives: Procedure: Skin and subcutaneous tissue sampling for histopathological analysis; Procedure: Blood sampling for laboratory analyses before and after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of microvascular density
Imunohistochemical analysis of skin and subcutaneous tissue samples to quantify microvascular density using CD31
Measured: Assessed on tissue samples collected during surgery
Degree of skin fibrosis
Histopathological analysis of skin and subcutaneous tissue samples to quantify fibrosis
Measured: Assessed on tissue samples collected during surgery
Secondary outcomes (6)
von Willebrand factor
Level of von Willebrand factor
Measured: Once, before surgery
Intraoperative hemodynamics
Monitoring of hypotension during surgery
Measured: During surgery
Vasoactive drugs
Need for the use of vasoactive drugs during surgery
Measured: During surgery
Blood transfusion during surgery
Need for blood product transfusions
Measured: During surgery
Postoperative laboratory parameters
Procalcitonin level
Measured: 16 hours after surgery
Postoperative laboratory parameters - CRP
C-reactive protein level
Measured: 16 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 posted20 Feb 2026
- Study start9 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal Carcinoma (CRC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josipa Glavas Tahtler, MD, Principal investigator, KBC Osijek, MEFOS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422974
- Sponsor's protocol ID
- CRC-NEO-001
- Acronym
- Neocolon
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of individual participant data (IPD) may be limited due to participant privacy, regulatory requirements, or informed consent restrictions. Data access will only be granted if ethical and legal conditions allow.
Publications
Elawa S, Fredriksson I, Steinvall I, Zotterman J, Farnebo S, Tesselaar E. Skin perfusion and oxygen saturation after mastectomy and radiation therapy in breast cancer patients. Breast. 2024 Jun;75:103704. doi: 10.1016/j.breast.2024.103704. Epub 2024 Mar 6.
PubMed 38460441Afolabi H, Salleh SM, Zakaria Z, Ch'ng ES, Mohd Nafi SN, Abdul Aziz AAB, Al-Mhanna SB, Wada Y, Abdulrahman AS. The Prediction of Survival Outcome and Prognosis Factor in Association with Comorbidity Status in Patients with Colorectal Cancer: A Research-Based Study. Healthcare (Basel). 2022 Sep 5;10(9):1693. doi: 10.3390/healthcare10091693.
PubMed 36141305Chen CC, Wu ML, Huang KC, Huang IP, Chung YL. The Effects of Neoadjuvant Treatment on the Tumor Microenvironment in Rectal Cancer: Implications for Immune Activation and Therapy Response. Clin Colorectal Cancer. 2020 Dec;19(4):e164-e180. doi: 10.1016/j.clcc.2020.04.002. Epub 2020 Apr 16.
PubMed 32387305Admasu FT, Dejenie TA, Ayehu GW, Zewde EA, Dessie G, Adugna DG, Enyew EF, Geto Z, Abebe EC. Evaluation of thromboembolic event, basic coagulation parameters, and associated factors in patients with colorectal cancer: a multicenter study. Front Oncol. 2023 May 2;13:1143122. doi: 10.3389/fonc.2023.1143122. eCollection 2023.
PubMed 37205202Lee S, Huh SJ, Oh SY, Koh MS, Kim SH, Lee JH, Han JY, Choi HJ, Kim SJ, Kim HJ. Clinical significance of coagulation factors in operable colorectal cancer. Oncol Lett. 2017 Jun;13(6):4669-4674. doi: 10.3892/ol.2017.6058. Epub 2017 Apr 20.
PubMed 28599468Gamboa AC, Lee RM, Turgeon MK, Varlamos C, Regenbogen SE, Hrebinko KA, Holder-Murray J, Wiseman JT, Ejaz A, Feng MP, Hawkins AT, Bauer P, Silviera M, Maithel SK, Balch GC. Impact of Postoperative Complications on Oncologic Outcomes After Rectal Cancer Surgery: An Analysis of the US Rectal Cancer Consortium. Ann Surg Oncol. 2021 Mar;28(3):1712-1721. doi: 10.1245/s10434-020-08976-8. Epub 2020 Sep 23.
PubMed 32968958Hanna DN, Hawkins AT. Colorectal: Management of Postoperative Complications in Colorectal Surgery. Surg Clin North Am. 2021 Oct;101(5):717-729. doi: 10.1016/j.suc.2021.05.016. Epub 2021 Jul 30.
PubMed 34537139
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection
- ClinicalTrials.gov ID
- NCT07422974
- Acronym / sponsor ID
- Neocolon / CRC-NEO-001
- Keywords
- Colorectal Carcinoma, Neoadjuvant Therapy, Microvascular Density, Treatment Outcome, Wound Healing, Critical care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Feb 2026 (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.
This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.
Detailed description
The study hypothesis is that neoadjuvant therapy of colorectal cancer leads to endothelial dysfunction, reduced microvascular density, and tissue fibrosis, and therefore contributes to the occurrence of perioperative complications. The primary objective of the study is to assess the association between microvascular density and neoadjuvant therapy, identify differences in biomarkers and demographic factors between patients with neoadjuvant therapy and those without neoadjuvant therapy, and compare clinical outcomes between patients treated with neoadjuvant therapy and those who underwent surgery as initial treatment. Secondary objectives are to determine the association of microvascular density and fibrosis in surgical wound tissue with postoperative complications and wound healing complications, and identify differences in biomarkers between patients with and without perioperative complications.
The study was approved by the Ethics Committee of the Osijek Clinical Hospital Center.
The study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy and 34 patients undergoing colorectal cancer surgery who did not receive neoadjuvant therapy but whose first-line treatment is surgery. During the surgery, a skin and subcutaneous tissue sample will be taken for pathohistological analysis of microvascular density and tissue fibrosis, allowing for a more detailed assessment of microvascular changes associated with perioperative complications. It is planned to follow the patient from the surgery until the end of hospitalization, and data on post-discharge complications will be tracked through the medical history in the Hospital Information System one month after discharge from the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who received neoadjuvant therapy. | – | Procedure: Skin and subcutaneous tissue sampling for histopathological analysis, Procedure: Blood sampling for laboratory analyses before and after surgeryThe study will include 34 consecutive patients undergoing colorectal cancer surgery who received neoadjuvant therapy. |
| Patients who did not receive neoadjuvant therapy, control group. | – | Procedure: Skin and subcutaneous tissue sampling for histopathological analysis, Procedure: Blood sampling for laboratory analyses before and after surgeryThe control group will include 34 patients undergoing colorectal cancer surgery who have not received neoadjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients (≥18 years) with histologically confirmed colorectal cancer who are scheduled for elective surgery, laparoscopic or open. Both sexes will be included in the study. The study population includes patients who received neoadjuvant therapy (study group) and those who did not (control group).
Key inclusion criteria (6 listed)
- Adults aged ≥18 years with histologically confirmed colorectal cancer
- Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy)
- Ability to understand the study protocol and provide written informed consent.
- Both sexes
- ASA classification II or III
Key exclusion criteria (5 listed)
- Age <18 years
- Patients who are not conscious, not oriented, or unable to provide informed consent
- Patients unable to understand the study protocol
- Emergency surgical cases
- Patients on chronic corticosteroid therapy
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 |
|---|---|---|
| Skin and subcutaneous tissue sampling for histopathological analysisDuring the operation, a sample of skin and subcutaneous tissue approximately 1 cm long and 2 mm wide will be taken from the surgical incision site. The sample will be taken from an area that has not previously been affected by radiotherapy and will not compromise patient safety. Histopathological analysis will be performed in the Clinical Department of Pathology and Forensic Medicine. The degree of fibrosis of the skin and subcutaneous tissue and the microvascular density of the skin tissue will be analyzed using the marker CD31 (PECAM-1). | Procedure or surgery | Patients who did not receive neoadjuvant therapy, control group., Patients who received neoadjuvant therapy. |
| Blood sampling for laboratory analyses before and after surgeryBefore surgery, blood samples will be taken for laboratory analysis. The following parameters will be assessed: leukocytes, hemoglobin, hematocrit, platelets, prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, urea, creatinine, blood glucose, potassium, AST, ALT, GGT, CRP, albumin, cholinesterase, IL-6, von Willebrand factor, and endothelin-1. Laboratory findings will be monitored 16 hours after surgery (leukocytes, hemoglobin, hematocrit, platelets, PV, fibrinogen, d-dimers, urea, creatinine, GUK, K, CRP, albumin, PCT, cholinesterase, IL-6) and before discharge from the hospital (leukocytes, hemoglobin, hematocrit, platelets, PV, urea, creatinine, GUK, K, CRP, albumin). Blood sampling will be conducted according to standard clinical protocols, ensuring patient safety and minimal discomfort. | Procedure or surgery | Patients who did not receive neoadjuvant therapy, control group., Patients who received neoadjuvant therapy. |
Primary outcome
Analysis of microvascular density
Time frame: Assessed on tissue samples collected during surgery
Imunohistochemical analysis of skin and subcutaneous tissue samples to quantify microvascular density using CD31
Degree of skin fibrosis
Time frame: Assessed on tissue samples collected during surgery
Histopathological analysis of skin and subcutaneous tissue samples to quantify fibrosis
6 secondary outcomes
von Willebrand factor
Time frame: Once, before surgery
Intraoperative hemodynamics
Time frame: During surgery
Vasoactive drugs
Time frame: During surgery
Blood transfusion during surgery
Time frame: During surgery
Postoperative laboratory parameters
Time frame: 16 hours after surgery
Postoperative laboratory parameters - CRP
Time frame: 16 hours after surgery
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 20 Feb 2026.
- Background: PubMed 38460441Elawa S, Fredriksson I, Steinvall I, Zotterman J, Farnebo S, Tesselaar E. Skin perfusion and oxygen saturation after mastectomy and radiation therapy in breast cancer patients. Breast. 2024 Jun;75:103704. doi: 10.1016/j.breast.2024.103704. Epub 2024 Mar 6.
- Background: PubMed 36141305Afolabi H, Salleh SM, Zakaria Z, Ch'ng ES, Mohd Nafi SN, Abdul Aziz AAB, Al-Mhanna SB, Wada Y, Abdulrahman AS. The Prediction of Survival Outcome and Prognosis Factor in Association with Comorbidity Status in Patients with Colorectal Cancer: A Research-Based Study. Healthcare (Basel). 2022 Sep 5;10(9):1693. doi: 10.3390/healthcare10091693.
- Background: PubMed 32387305Chen CC, Wu ML, Huang KC, Huang IP, Chung YL. The Effects of Neoadjuvant Treatment on the Tumor Microenvironment in Rectal Cancer: Implications for Immune Activation and Therapy Response. Clin Colorectal Cancer. 2020 Dec;19(4):e164-e180. doi: 10.1016/j.clcc.2020.04.002. Epub 2020 Apr 16.
- Background: PubMed 37205202Admasu FT, Dejenie TA, Ayehu GW, Zewde EA, Dessie G, Adugna DG, Enyew EF, Geto Z, Abebe EC. Evaluation of thromboembolic event, basic coagulation parameters, and associated factors in patients with colorectal cancer: a multicenter study. Front Oncol. 2023 May 2;13:1143122. doi: 10.3389/fonc.2023.1143122. eCollection 2023.
- Background: PubMed 28599468Lee S, Huh SJ, Oh SY, Koh MS, Kim SH, Lee JH, Han JY, Choi HJ, Kim SJ, Kim HJ. Clinical significance of coagulation factors in operable colorectal cancer. Oncol Lett. 2017 Jun;13(6):4669-4674. doi: 10.3892/ol.2017.6058. Epub 2017 Apr 20.
- Background: PubMed 32968958Gamboa AC, Lee RM, Turgeon MK, Varlamos C, Regenbogen SE, Hrebinko KA, Holder-Murray J, Wiseman JT, Ejaz A, Feng MP, Hawkins AT, Bauer P, Silviera M, Maithel SK, Balch GC. Impact of Postoperative Complications on Oncologic Outcomes After Rectal Cancer Surgery: An Analysis of the US Rectal Cancer Consortium. Ann Surg Oncol. 2021 Mar;28(3):1712-1721. doi: 10.1245/s10434-020-08976-8. Epub 2020 Sep 23.
- Background: PubMed 34537139Hanna DN, Hawkins AT. Colorectal: Management of Postoperative Complications in Colorectal Surgery. Surg Clin North Am. 2021 Oct;101(5):717-729. doi: 10.1016/j.suc.2021.05.016. Epub 2021 Jul 30.
- Cancer today; Data visualization tools for exploring the global cancer burden in 2022Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Sharing of individual participant data (IPD) may be limited due to participant privacy, regulatory requirements, or informed consent restrictions. Data access will only be granted if ethical and legal conditions allow.
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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.
Josipa Glavas Tahtler, MD principal investigator
KBC Osijek, MEFOS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Carcinoma (CRC) and Complications, run by Osijek University Hospital at 1 site in Croatia.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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 Josipa Glavas Tahtler, MD (00385959080119, glavasjosipa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of microvascular density (time frame: Assessed on tissue samples collected during 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 NCT07422974, which also lists 7 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 20 Feb 2026.