Epithelial Ovarian CancerSUROVANCT06223763
SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery
An observational study of Epithelial Ovarian Cancer and Fallopian Tube Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- What is being tested?
- Cytoreductive surgery, Neoadjuvant chemotherapy and Adjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive participant sampling of patients with IIIB-IVB ovarian cancer that underwent primary cytoreductive surgery or interval cytoreductive surgery.
Who may be able to join
- Patients > 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at the time of the surgery.
- Invasive high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma in stage International Federation of Gynecology and Obstetrics (FIGO) IIIB-IVB (IVB only if resectable metastases are present), suspected or histologically confirmed and newly diagnosed.
- Patient underwent primary surgery or first course of neoadjuvant chemotherapy between January 1, 2018, and December 31, 2019.
- American Society of Anesthesiologists Physical Status Classification System (ASA) score 1 or 2 at the time of the surgery.
- Surgery performed by laparotomy with an attempt of maximal effort.
Show all 11Show fewer
- The surgeon must be a certified or non-certified gynecologic oncologist.
- Based on all available information before the surgery (primary or interval), the patient was considered completely resectable.
- Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- Preoperative imaging (either CT, whole-body MRI, or positron emission tomography (PET)-CT) excluding unresectable disease as per European Society of Gynaecological Oncology (ESGO) criteria.
- Surgical report on residual disease after surgery.
Who cannot join
- Non-epithelial malignant ovarian neoplasms and borderline tumors.
- Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
- Recurrent ovarian cancer.
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
- Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis before surgery (primary or interval).
- Pregnant women at the time of diagnosis.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Universidad de Navarra
Madrid, 28027
Luis M Chiva, MD, PhD, 682486041 ext. +34, lchiva@unav.es
lchiva@unav.es
About this study
Official title: An International Retrospective Observational Study Comparing Primary Cytoreductive Surgery With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Patients With Carcinoma of the Ovary, Fallopian Tubes and Peritoneum
An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum.
Read the detailed description
SUROVA study tries to compare the outcomes of primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum operated between 2018 and 2019 worldwide.
The objective is to know if the surgical approach influences our patients' survival (OS and PFS). To answer this question, SUROVA is necessary.
While the prospective Trust Trial, with results expected in 2024, is designed to address this question, a limitation of this study is that it is confined to patients treated in high-end hospitals. This limitation could introduce bias in the results, as many patients may lack access to such high-level healthcare facilities. Therefore, the objective is to extend the scope of this study to real life. To achieve this, the investigators are seeking to collect data from patients treated globally during 2018 and 2019, involving both primary and interval cytoreduction.
The investigators hope that the results of this study will be subjected to evaluation at international meetings and published in reputable international journals. Authorship will be based on a rigorous criterion tied to the number of valid cases included in the study. Naturally, the aim is to include as many authors as possible.
The researchers strongly believe that patients would greatly benefit from SUROVA data and that it will address this critical question and provide invaluable insights.
- Being tested
- Cytoreductive surgery, Neoadjuvant chemotherapy, Adjuvant chemotherapy
- Keywords
- surgery, gynecology, gynecological surgery, ovarian cancer, neoadjuvant chemotherapy, interval cytoreductive surgery, cytoreductive surgery
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgeryProcedure or surgery
Also called debulking surgery, cytoreduction
Cytoreductive surgery is a surgical procedure performed with the goal of reducing the tumor burden in the body. This type of surgery is commonly used in the treatment of certain types of cancers, especially in the context of peritoneal carcinomatosis. During cytoreductive surgery, the surgeon attempts to remove as much visible tumor as possible. This may involve the removal of tumors from specific organs and the elimination of tumor lesions on the surface of intra-abdominal organs.
Neoadjuvant chemotherapyDrug
Neoadjuvant chemotherapy refers to chemotherapy administered before the primary treatment in cancer management. The goals include reducing tumor size, treating micrometastases, assessing treatment response, converting inoperable tumors to operable ones, and preserving organs or tissues.
Adjuvant chemotherapyDrug
Adjuvant chemotherapy is chemotherapy given after the primary treatment, such as surgery or radiation therapy, with the aim of eliminating any remaining cancer cells and reducing the risk of recurrence. It is administered to patients who have undergone the initial treatment to enhance the overall effectiveness of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Primary cytoreductive surgery | Patients underwent primary cytoreductive surgery between January 1, 2018, and December 31, 2019. After that, they underwent adjuvant therapy. Receives: Procedure: Cytoreductive surgery; Drug: Adjuvant chemotherapy | |
| Interval cytoreductive surgery | Patients underwent primary first course of neoadjuvant chemotherapy between January 1, 2018, and December 31, 2019. After neoadjuvant chemotherapy, the patient underwent interval cytoreductive surgery and then, adjuvant chemotherapy. Receives: Procedure: Cytoreductive surgery; Drug: Neoadjuvant chemotherapy; Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival at 5 years
Compare overall survival (OS) at 5 years in patients who underwent primary cytoreductive surgery vs. neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB-IVB ovarian cancer.
Measured: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up, assessed at the 5-year mark.
Secondary outcomes (7)
Progression Free Survival at 5 years
Compare Progression Free Survival (PFS) at 5 years in patients who underwent primary cytoreductive surgery vs. neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB-IVB ovarian cancer.
Measured: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.
Time to first and second subsequent anticancer therapy or death.
Time to first subsequent anticancer therapy is calculated from the date of first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) until the starting date of the first subsequent anticancer therapy or death, whichever occurs first or date of last contact (censored observation). Maintenance treatments following a cytostatic treatment are not considered separate treatment lines.
Measured: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.
Information on surgical treatment approaches
Gather information on surgical treatment approaches and decision-making processes for patients with advanced high-grade ovarian cancer in worldwide centers
Measured: Date of last contact up to 5 years
Aletti surgical score
Extend the surgery according to the Aletti surgical complexity score, which ranges from 1 to 8, with higher scores indicating more complex surgeries.
Measured: Date of last contact up to 5 years
Surgical complications: requirement of pharmacological treatment; surgical, endoscopic or radiological intervention, life threatening complications or death.
Documentation of surgical complications.
Measured: Date of last contact up to 5 years
Breast cancer susceptibility gene (BRCA) influence
Compare the outcomes between patients with BRCA mutations and those without this mutation
Measured: Date of last contact up to 5 years
Homologous Recombination Deficiency (HRD) deficiency influence
Compare the outcomes between patients with HRD deficiency and those with HRD proficiency
Measured: Date of last contact up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian CancerStudies 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra
- Responsible party
- Sponsor
- Investigators
- Luis M Chiva, MD, PhD, Study chair, University of NavarraPilar Ordás, PhD student, Study chair, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223763
- Sponsor's protocol ID
- SUROVA
- Acronym
- SUROVA
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chiva L, Ordas P, Mishra J, Ayhan A, Lee YY, Bogani G, Sp S, Lomnytska M, Stukan M, Fruscio R, Chura BF, Salcedo-Hernandez RA, De Iaco P, Haidopoulos D, Svintsitskiy V, Jain V, Stanciu P, Rawert FL, Akdemir C, Abdallah R, Chacon E, Minguez JA, Gil-Moreno A, Kharchenko K, Mofrad MH, Gebauer G, Diaz-Feijoo B, Scibilia G, Klaric M, Skof E, Saadeh FA, Mueller MD, Saarelainen S, Tejerizo Garcia A, Fotopoulou C, Coronado P, Dermikiran F, Goffin F, Tsolakidis D, Gonzalez-Martin A; SUROVA Study Group. SUROVA study: global real-world treatment strategies and mortality risk prediction in advanced ovarian cancer. Int J Gynecol Cancer. 2025 Dec;35(12):102688. doi: 10.1016/j.ijgc.2025.102688.
PubMed 41352872Chiva L, Ordas P, Martin-Calvo N, Aramendia JM, Sanchez Lorenzo L, Gallego Martinez A, Vizcay A, Minguez JA, Manzour N, Vazquez-Vicente D, Chacon E, Castellanos T, Gonzalez Martin A. An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum (SUROVA trial). Int J Gynecol Cancer. 2024 Jun 3;34(6):942-945. doi: 10.1136/ijgc-2024-005354.
PubMed 38479803
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Retrospective Observational Study Comparing Primary Cytoreductive Surgery With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Patients With Carcinoma of the Ovary, Fallopian Tubes and Peritoneum
- ClinicalTrials.gov ID
- NCT06223763
- Acronym / sponsor ID
- SUROVA / SUROVA
- Keywords
- surgery, gynecology, gynecological surgery, ovarian cancer, neoadjuvant chemotherapy, interval cytoreductive surgery, cytoreductive surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- University of Navarra
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum.
Detailed description
SUROVA study tries to compare the outcomes of primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum operated between 2018 and 2019 worldwide.
The objective is to know if the surgical approach influences our patients' survival (OS and PFS). To answer this question, SUROVA is necessary.
While the prospective Trust Trial, with results expected in 2024, is designed to address this question, a limitation of this study is that it is confined to patients treated in high-end hospitals. This limitation could introduce bias in the results, as many patients may lack access to such high-level healthcare facilities. Therefore, the objective is to extend the scope of this study to real life. To achieve this, the investigators are seeking to collect data from patients treated globally during 2018 and 2019, involving both primary and interval cytoreduction.
The investigators hope that the results of this study will be subjected to evaluation at international meetings and published in reputable international journals. Authorship will be based on a rigorous criterion tied to the number of valid cases included in the study. Naturally, the aim is to include as many authors as possible.
The researchers strongly believe that patients would greatly benefit from SUROVA data and that it will address this critical question and provide invaluable insights.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary cytoreductive surgery | – | Procedure: Cytoreductive surgery, Drug: Adjuvant chemotherapyPatients underwent primary cytoreductive surgery between January 1, 2018, and December 31, 2019. After that, they underwent adjuvant therapy. |
| Interval cytoreductive surgery | – | Procedure: Cytoreductive surgery, Drug: Neoadjuvant chemotherapy, Drug: Adjuvant chemotherapyPatients underwent primary first course of neoadjuvant chemotherapy between January 1, 2018, and December 31, 2019. After neoadjuvant chemotherapy, the patient underwent interval cytoreductive surgery and then, adjuvant chemotherapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive participant sampling of patients with IIIB-IVB ovarian cancer that underwent primary cytoreductive surgery or interval cytoreductive surgery.
Key inclusion criteria (11 listed)
- Patients > 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at the time of the surgery.
- Invasive high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma in stage International Federation of Gynecology and Obstetrics (FIGO) IIIB-IVB (IVB only if resectable metastases are present), suspected or histologically confirmed and newly diagnosed.
- Patient underwent primary surgery or first course of neoadjuvant chemotherapy between January 1, 2018, and December 31, 2019.
- American Society of Anesthesiologists Physical Status Classification System (ASA) score 1 or 2 at the time of the surgery.
Key exclusion criteria (6 listed)
- Non-epithelial malignant ovarian neoplasms and borderline tumors.
- Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
- Recurrent ovarian cancer.
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
- Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis before surgery (primary or interval).
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 |
|---|---|---|
| Cytoreductive surgeryAlso: debulking surgery, cytoreductionCytoreductive surgery is a surgical procedure performed with the goal of reducing the tumor burden in the body. This type of surgery is commonly used in the treatment of certain types of cancers, especially in the context of peritoneal carcinomatosis. During cytoreductive surgery, the surgeon attempts to remove as much visible tumor as possible. This may involve the removal of tumors from specific organs and the elimination of tumor lesions on the surface of intra-abdominal organs. | Procedure or surgery | Interval cytoreductive surgery, Primary cytoreductive surgery |
| Neoadjuvant chemotherapyNeoadjuvant chemotherapy refers to chemotherapy administered before the primary treatment in cancer management. The goals include reducing tumor size, treating micrometastases, assessing treatment response, converting inoperable tumors to operable ones, and preserving organs or tissues. | Drug | Interval cytoreductive surgery |
| Adjuvant chemotherapyAdjuvant chemotherapy is chemotherapy given after the primary treatment, such as surgery or radiation therapy, with the aim of eliminating any remaining cancer cells and reducing the risk of recurrence. It is administered to patients who have undergone the initial treatment to enhance the overall effectiveness of the therapy. | Drug | Interval cytoreductive surgery, Primary cytoreductive surgery |
Primary outcome
Overall Survival at 5 years
Time frame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up, assessed at the 5-year mark.
Compare overall survival (OS) at 5 years in patients who underwent primary cytoreductive surgery vs. neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB-IVB ovarian cancer.
7 secondary outcomes
Progression Free Survival at 5 years
Time frame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.
Time to first and second subsequent anticancer therapy or death.
Time frame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.
Information on surgical treatment approaches
Time frame: Date of last contact up to 5 years
Aletti surgical score
Time frame: Date of last contact up to 5 years
Surgical complications: requirement of pharmacological treatment; surgical, endoscopic or radiological intervention, life threatening complications or death.
Time frame: Date of last contact up to 5 years
Breast cancer susceptibility gene (BRCA) influence
Time frame: Date of last contact up to 5 years
Homologous Recombination Deficiency (HRD) deficiency influence
Time frame: Date of last contact up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 41352872Chiva L, Ordas P, Mishra J, Ayhan A, Lee YY, Bogani G, Sp S, Lomnytska M, Stukan M, Fruscio R, Chura BF, Salcedo-Hernandez RA, De Iaco P, Haidopoulos D, Svintsitskiy V, Jain V, Stanciu P, Rawert FL, Akdemir C, Abdallah R, Chacon E, Minguez JA, Gil-Moreno A, Kharchenko K, Mofrad MH, Gebauer G, Diaz-Feijoo B, Scibilia G, Klaric M, Skof E, Saadeh FA, Mueller MD, Saarelainen S, Tejerizo Garcia A, Fotopoulou C, Coronado P, Dermikiran F, Goffin F, Tsolakidis D, Gonzalez-Martin A; SUROVA Study Group. SUROVA study: global real-world treatment strategies and mortality risk prediction in advanced ovarian cancer. Int J Gynecol Cancer. 2025 Dec;35(12):102688. doi: 10.1016/j.ijgc.2025.102688.
- Derived from this study: PubMed 38479803Chiva L, Ordas P, Martin-Calvo N, Aramendia JM, Sanchez Lorenzo L, Gallego Martinez A, Vizcay A, Minguez JA, Manzour N, Vazquez-Vicente D, Chacon E, Castellanos T, Gonzalez Martin A. An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum (SUROVA trial). Int J Gynecol Cancer. 2024 Jun 3;34(6):942-945. doi: 10.1136/ijgc-2024-005354.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Luis M Chiva, MD, PhD study chair
University of Navarra
Pilar Ordás, PhD student study chair
University of Navarra
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 Epithelial Ovarian Cancer and Fallopian Tube Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis M Chiva, MD, PhD (0034682486041 ext. 34, lchiva@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival at 5 years (time frame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up, assessed at the 5-year mark.). 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 NCT06223763, which also lists 2 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 25 Jan 2024.