Neuroendocrine TumorsNCT04331912
PFS and OS of Patients With Advanced Neuroendocrine Cancer (NEN) After Systemic Treatment
An observational study of Neuroendocrine Tumors, run by University of Warmia and Mazury at 2 sites in Poland.
Trial summary
This is a retrospective study. The analysis includes patients with advanced neuroendocrine cancer (NEN) treated with systemic therapy, because of inoperable primary tumor or/and metastasis, clinical, imaging, biochemical disease progression and no standard method of treatment hormone overproduction symptoms. Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jul 2019to 31 Dec 2023
- 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 18 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is planned on a group 1500 patients with advanced, histopathologically confirmed neuroendocrine neoplasms (NEN) treated with different schedule of systemic treatment including: somatostatin receptor analogues, molecular targeted therapy (sunitinib or everolimus), chemotherapy using different therapeutic regimens and peptide receptor radioisotope therapy (Peptide Receptor Radionuclide Therapy). Research on NEN patients will include the following groups of patients: 1. NEN from digestive system, 2. respiratory system; 3. Other NEN tumours including PPGL, cancer of known primary and very rare NEN tumours like gynecological or urological primary NET. 4. NEN connected with genetic syndromes like: MEN1, MEN2, VHL, NF1, SDHx.
Who may be able to join
- Adults ≥18 years old, male or female,
- Patients with histopathological confirmation of advanced neuroendocrine cancer (NEN),
- Patients with NETG1, NETG2 based on Ki-67,
- Patients with diagnosed NEN, who did not receive prior treatment and were qualified to systemic treatment,
- Patients with advanced NEN who previously received first-line systemic therapy or second-line systemic therapy,
- Patients with advanced, inoperable NEN cancer before the treatment, during the treatment and after the treatment regardless of lines of systemic therapy,
- Patients with diagnosed NEN and performance status (PS) ≤3 according to ECOG/WHO classification, who received systemic therapy.
Who cannot join
- Patients without histopathological confirmation of neuroendocrine carcinoma (NEN),
- Patients with diagnosed another type of cancer or benign tumor confirmed in histopathological examination,
- Patients treated prior with intention to treat (ITT),
- Patients with residual disease in further clinical follow-up without active systemic treatment,
- Patients with advanced, progressive and poor performance status, who were disqualified from further systemic treatment,
- Patients, who finished treatment during first month or their further disease process was unknown.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
University of Warmia and Mazury in Olsztyn
Olsztyn, Warmian-Masurian Voivodeship, 10-082
Jarosław B Ćwikła, MD, PhD, +48 602112599, jbcwikla@interia.pl
- Recruiting
Diagnostic and Therapy Center - Gammed
Warsaw, 02-351
Jarosław B Ćwikła, M.D., +48602112599, jbcwikla@interia.pl
Alina Czepukojć, +48507089942, gammed@gammed.pl
About this study
Official title: Outcomes of Patients With Advanced Neuroendocrine Cancer (NEN) Treated With Systemic Treatment: Somatostatin Analogues, Molecular Targeted Therapy, Chemotherapy and Peptide Radioisotope Therapy - a Retrospective Analysis.
This is a retrospective study. The analysis includes patients with advanced neuroendocrine cancer (NEN) treated with systemic therapy, because of inoperable primary tumor or/and metastasis, clinical, imaging, biochemical disease progression and no standard method of treatment hormone overproduction symptoms. The data of patients with advanced NEN with histopathological confirmation is collected from medical records. The progression-free survival (PFS), overall survival (OS) and influence of various factors on survival will be estimated. The research will be conducted for above 3 years on planned group 1500 patients. The aim of the study is to estimate median OS and PFS in advanced NEN patients treated with different schedule of systemic treatment.
Read the detailed description
This is a retrospective study. The analysis includes patients with advanced neuroendocrine cancer (NEN) treated with systemic therapy, because of inoperable primary tumor or/and metastasis, clinical, imaging, biochemical disease progression and no standard method of treatment hormone overproduction symptoms. Systemic treatment including: somatostatin receptor analogues, molecular targeted therapy (sunitinib and everolimus), chemotherapy and peptide radioisotope therapy (Peptide Receptor Radionuclide Therapy). The data of patients with advanced NEN with histopathological or/and clinical or/and biochemical confirmation is collected from medical records. Neuroendocrine cancer from digestive system, respiratory system and another rarely occurring cancer including cancer connected with genetic syndromes like: MEN1, MEN2, VHL, NF1, SDHx will be included. The progression-free survival (PFS), overall survival (OS) and influence of various factors on survival will be estimated. Analyzed factors: age, sex, ethnicity, specific symptoms at the time of diagnosis, carcinoid heart disease, level of 5HIAA in DZM, level of CgA, liver test, size of tumor, cell differentiation of tumor based on Ki-67 index, liver metastases. The research will be conducted for above 3 years since July 2019 till December 2022 on planned group 1500 patients. The aim of the study is to estimate median OS and PFS in advanced NEN patients treated with different schedule of systemic treatment. The second goal is to create clinical practice recommendation based on potential prognostic factors of OS and PFS due to type of therapy in different NEN subgroups.
- Conditions
- Neuroendocrine Tumors
- Keywords
- NEN-neuroendocrine cancer, overall survival, OS - overall survival, PFS - progression-free survival
- Medical subject headings
- Neuroendocrine Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS - Progression Free Survival
the time from the start of systemic treatment date to the date of first documented disease progression (event: disease progression - DP, based on RECIST, death, adverse events, which provide to disqualification from further therapy). Patients without progression at the time of analysis will be censored.
Measured: 7 years
OS - Overall Survival
is defined as the time from the start of systemic treatment date to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
Measured: 7 years
Secondary outcomes (2)
Log-rank test
assessment of differences in survival of patients between subgroups
Measured: 7 years
Cox proportional-hazards model
uni- and multivariate analyses used for investigating the association between the survival time of patients and prognostic factors
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jul 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaroslaw B. Cwikla, MD, PhD, Professor UWM, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331912
- Sponsor's protocol ID
- NEN_2019
- Status last verified
- May 2021
- First submitted
- 31 Mar 2020
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Modlin IM, Shapiro MD, Kidd M. Siegfried Oberndorfer: origins and perspectives of carcinoid tumors. Hum Pathol. 2004 Dec;35(12):1440-51. doi: 10.1016/j.humpath.2004.09.018.
PubMed 15619202Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008 Jan;9(1):61-72. doi: 10.1016/S1470-2045(07)70410-2.
PubMed 18177818Modlin IM, Champaneria MC, Bornschein J, Kidd M. Evolution of the diffuse neuroendocrine system--clear cells and cloudy origins. Neuroendocrinology. 2006;84(2):69-82. doi: 10.1159/000096997. Epub 2006 Nov 9.
PubMed 17106184Modlin IM, Lye KD, Kidd M. A 5-decade analysis of 13,715 carcinoid tumors. Cancer. 2003 Feb 15;97(4):934-59. doi: 10.1002/cncr.11105.
PubMed 12569593Kloppel G, Perren A, Heitz PU. The gastroenteropancreatic neuroendocrine cell system and its tumors: the WHO classification. Ann N Y Acad Sci. 2004 Apr;1014:13-27. doi: 10.1196/annals.1294.002.
PubMed 15153416Greene FL. TNM staging for malignancies of the digestive tract: 2003 changes and beyond. Semin Surg Oncol. 2003;21(1):23-9. doi: 10.1002/ssu.10018.
PubMed 12923913Kloppel G, Rindi G, Perren A, Komminoth P, Klimstra DS. The ENETS and AJCC/UICC TNM classifications of the neuroendocrine tumors of the gastrointestinal tract and the pancreas: a statement. Virchows Arch. 2010 Jun;456(6):595-7. doi: 10.1007/s00428-010-0924-6. Epub 2010 Apr 27. No abstract available.
PubMed 20422210Washington MK, Tang LH, Berlin J, Branton PA, Burgart LJ, Carter DK, Compton CC, Fitzgibbons PL, Frankel WL, Jessup JM, Kakar S, Minsky B, Nakhleh RE; Members of the Cancer Committee, College of American Pathologists. Protocol for the examination of specimens from patients with neuroendocrine tumors (carcinoid tumors) of the small intestine and ampulla. Arch Pathol Lab Med. 2010 Feb;134(2):181-6. doi: 10.5858/134.2.181. No abstract available.
PubMed 20121604Rindi G, Kloppel G, Couvelard A, Komminoth P, Korner M, Lopes JM, McNicol AM, Nilsson O, Perren A, Scarpa A, Scoazec JY, Wiedenmann B. TNM staging of midgut and hindgut (neuro) endocrine tumors: a consensus proposal including a grading system. Virchows Arch. 2007 Oct;451(4):757-62. doi: 10.1007/s00428-007-0452-1. Epub 2007 Aug 3.
PubMed 17674042Klimstra DS, Modlin IR, Adsay NV, Chetty R, Deshpande V, Gonen M, Jensen RT, Kidd M, Kulke MH, Lloyd RV, Moran C, Moss SF, Oberg K, O'Toole D, Rindi G, Robert ME, Suster S, Tang LH, Tzen CY, Washington MK, Wiedenmann B, Yao J. Pathology reporting of neuroendocrine tumors: application of the Delphic consensus process to the development of a minimum pathology data set. Am J Surg Pathol. 2010 Mar;34(3):300-13. doi: 10.1097/PAS.0b013e3181ce1447.
PubMed 20118772Modlin IM, Gustafsson BI, Pavel M, Svejda B, Lawrence B, Kidd M. A nomogram to assess small-intestinal neuroendocrine tumor ('carcinoid') survival. Neuroendocrinology. 2010;92(3):143-57. doi: 10.1159/000319784. Epub 2010 Aug 23.
PubMed 20733279Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. No abstract available.
PubMed 26784901Niederle B, Pape UF, Costa F, Gross D, Kelestimur F, Knigge U, Oberg K, Pavel M, Perren A, Toumpanakis C, O'Connor J, O'Toole D, Krenning E, Reed N, Kianmanesh R; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Neuroendocrine Neoplasms of the Jejunum and Ileum. Neuroendocrinology. 2016;103(2):125-38. doi: 10.1159/000443170. Epub 2016 Jan 12. No abstract available.
PubMed 26758972Ramage JK, De Herder WW, Delle Fave G, Ferolla P, Ferone D, Ito T, Ruszniewski P, Sundin A, Weber W, Zheng-Pei Z, Taal B, Pascher A; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Colorectal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):139-43. doi: 10.1159/000443166. Epub 2016 Jan 5. No abstract available.
PubMed 26730835Pape UF, Niederle B, Costa F, Gross D, Kelestimur F, Kianmanesh R, Knigge U, Oberg K, Pavel M, Perren A, Toumpanakis C, O'Connor J, Krenning E, Reed N, O'Toole D; Vienna Consensus Conference participants. ENETS Consensus Guidelines for Neuroendocrine Neoplasms of the Appendix (Excluding Goblet Cell Carcinomas). Neuroendocrinology. 2016;103(2):144-52. doi: 10.1159/000443165. Epub 2016 Jan 5. No abstract available.
PubMed 26730583
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients With Advanced Neuroendocrine Cancer (NEN) Treated With Systemic Treatment: Somatostatin Analogues, Molecular Targeted Therapy, Chemotherapy and Peptide Radioisotope Therapy - a Retrospective Analysis.
- ClinicalTrials.gov ID
- NCT04331912
- Acronym / sponsor ID
- NEN_2019
- Conditions
- Neuroendocrine Tumors
- Keywords
- NEN-neuroendocrine cancer, overall survival, OS - overall survival, PFS - progression-free survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Warmia and MazuryUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Apr 2020 (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 is a retrospective study. The analysis includes patients with advanced neuroendocrine cancer (NEN) treated with systemic therapy, because of inoperable primary tumor or/and metastasis, clinical, imaging, biochemical disease progression and no standard method of treatment hormone overproduction symptoms. The data of patients with advanced NEN with histopathological confirmation is collected from medical records. The progression-free survival (PFS), overall survival (OS) and influence of various factors on survival will be estimated. The research will be conducted for above 3 years on planned group 1500 patients. The aim of the study is to estimate median OS and PFS in advanced NEN patients treated with different schedule of systemic treatment.
Detailed description
This is a retrospective study. The analysis includes patients with advanced neuroendocrine cancer (NEN) treated with systemic therapy, because of inoperable primary tumor or/and metastasis, clinical, imaging, biochemical disease progression and no standard method of treatment hormone overproduction symptoms. Systemic treatment including: somatostatin receptor analogues, molecular targeted therapy (sunitinib and everolimus), chemotherapy and peptide radioisotope therapy (Peptide Receptor Radionuclide Therapy). The data of patients with advanced NEN with histopathological or/and clinical or/and biochemical confirmation is collected from medical records. Neuroendocrine cancer from digestive system, respiratory system and another rarely occurring cancer including cancer connected with genetic syndromes like: MEN1, MEN2, VHL, NF1, SDHx will be included. The progression-free survival (PFS), overall survival (OS) and influence of various factors on survival will be estimated. Analyzed factors: age, sex, ethnicity, specific symptoms at the time of diagnosis, carcinoid heart disease, level of 5HIAA in DZM, level of CgA, liver test, size of tumor, cell differentiation of tumor based on Ki-67 index, liver metastases. The research will be conducted for above 3 years since July 2019 till December 2022 on planned group 1500 patients. The aim of the study is to estimate median OS and PFS in advanced NEN patients treated with different schedule of systemic treatment. The second goal is to create clinical practice recommendation based on potential prognostic factors of OS and PFS due to type of therapy in different NEN subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is planned on a group 1500 patients with advanced, histopathologically confirmed neuroendocrine neoplasms (NEN) treated with different schedule of systemic treatment including: somatostatin receptor analogues, molecular targeted therapy (sunitinib or everolimus), chemotherapy using different therapeutic regimens and peptide receptor radioisotope therapy (Peptide Receptor Radionuclide Therapy). Research on NEN patients will include the following groups of patients: 1. NEN from digestive system, 2. respiratory system; 3. Other NEN tumours including PPGL, cancer of known primary and very rare NEN tumours like gynecological or urological primary NET. 4. NEN connected with genetic syndromes like: MEN1, MEN2, VHL, NF1, SDHx.
Key inclusion criteria (7 listed)
- Adults ≥18 years old, male or female,
- Patients with histopathological confirmation of advanced neuroendocrine cancer (NEN),
- Patients with NETG1, NETG2 based on Ki-67,
- Patients with diagnosed NEN, who did not receive prior treatment and were qualified to systemic treatment,
- Patients with advanced NEN who previously received first-line systemic therapy or second-line systemic therapy,
Key exclusion criteria (6 listed)
- Patients without histopathological confirmation of neuroendocrine carcinoma (NEN),
- Patients with diagnosed another type of cancer or benign tumor confirmed in histopathological examination,
- Patients treated prior with intention to treat (ITT),
- Patients with residual disease in further clinical follow-up without active systemic treatment,
- Patients with advanced, progressive and poor performance status, who were disqualified from further systemic treatment,
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
PFS - Progression Free Survival
Time frame: 7 years
the time from the start of systemic treatment date to the date of first documented disease progression (event: disease progression - DP, based on RECIST, death, adverse events, which provide to disqualification from further therapy). Patients without progression at the time of analysis will be censored.
OS - Overall Survival
Time frame: 7 years
is defined as the time from the start of systemic treatment date to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
2 secondary outcomes
Log-rank test
Time frame: 7 years
Cox proportional-hazards model
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Results publication: PubMed 15619202Modlin IM, Shapiro MD, Kidd M. Siegfried Oberndorfer: origins and perspectives of carcinoid tumors. Hum Pathol. 2004 Dec;35(12):1440-51. doi: 10.1016/j.humpath.2004.09.018.
- Results publication: PubMed 18177818Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008 Jan;9(1):61-72. doi: 10.1016/S1470-2045(07)70410-2.
- Results publication: PubMed 17106184Modlin IM, Champaneria MC, Bornschein J, Kidd M. Evolution of the diffuse neuroendocrine system--clear cells and cloudy origins. Neuroendocrinology. 2006;84(2):69-82. doi: 10.1159/000096997. Epub 2006 Nov 9.
- Results publication: PubMed 12569593Modlin IM, Lye KD, Kidd M. A 5-decade analysis of 13,715 carcinoid tumors. Cancer. 2003 Feb 15;97(4):934-59. doi: 10.1002/cncr.11105.
- Results publication: PubMed 15153416Kloppel G, Perren A, Heitz PU. The gastroenteropancreatic neuroendocrine cell system and its tumors: the WHO classification. Ann N Y Acad Sci. 2004 Apr;1014:13-27. doi: 10.1196/annals.1294.002.
- Results publication: PubMed 12923913Greene FL. TNM staging for malignancies of the digestive tract: 2003 changes and beyond. Semin Surg Oncol. 2003;21(1):23-9. doi: 10.1002/ssu.10018.
- Results publication: PubMed 20422210Kloppel G, Rindi G, Perren A, Komminoth P, Klimstra DS. The ENETS and AJCC/UICC TNM classifications of the neuroendocrine tumors of the gastrointestinal tract and the pancreas: a statement. Virchows Arch. 2010 Jun;456(6):595-7. doi: 10.1007/s00428-010-0924-6. Epub 2010 Apr 27. No abstract available.
- Results publication: PubMed 20121604Washington MK, Tang LH, Berlin J, Branton PA, Burgart LJ, Carter DK, Compton CC, Fitzgibbons PL, Frankel WL, Jessup JM, Kakar S, Minsky B, Nakhleh RE; Members of the Cancer Committee, College of American Pathologists. Protocol for the examination of specimens from patients with neuroendocrine tumors (carcinoid tumors) of the small intestine and ampulla. Arch Pathol Lab Med. 2010 Feb;134(2):181-6. doi: 10.5858/134.2.181. No abstract available.
- Results publication: PubMed 17674042Rindi G, Kloppel G, Couvelard A, Komminoth P, Korner M, Lopes JM, McNicol AM, Nilsson O, Perren A, Scarpa A, Scoazec JY, Wiedenmann B. TNM staging of midgut and hindgut (neuro) endocrine tumors: a consensus proposal including a grading system. Virchows Arch. 2007 Oct;451(4):757-62. doi: 10.1007/s00428-007-0452-1. Epub 2007 Aug 3.
- Results publication: PubMed 20118772Klimstra DS, Modlin IR, Adsay NV, Chetty R, Deshpande V, Gonen M, Jensen RT, Kidd M, Kulke MH, Lloyd RV, Moran C, Moss SF, Oberg K, O'Toole D, Rindi G, Robert ME, Suster S, Tang LH, Tzen CY, Washington MK, Wiedenmann B, Yao J. Pathology reporting of neuroendocrine tumors: application of the Delphic consensus process to the development of a minimum pathology data set. Am J Surg Pathol. 2010 Mar;34(3):300-13. doi: 10.1097/PAS.0b013e3181ce1447.
- Results publication: PubMed 20733279Modlin IM, Gustafsson BI, Pavel M, Svejda B, Lawrence B, Kidd M. A nomogram to assess small-intestinal neuroendocrine tumor ('carcinoid') survival. Neuroendocrinology. 2010;92(3):143-57. doi: 10.1159/000319784. Epub 2010 Aug 23.
- Results publication: PubMed 26784901Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. No abstract available.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by University of Warmia and Mazury at 2 sites in Poland.
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 7 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 Jarosław B Ćwikła, MD, PhD (+48 602112599, jbcwikla@interia.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS - Progression Free Survival (time frame: 7 years). 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 NCT04331912, which also lists 20 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 May 2021.