Malignant Solid TumorsREGATANCT05539677
Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
An observational study of Malignant Solid Tumors and Primary Brain Tumor, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Malignant Solid Tumors, Primary Brain Tumor, Melanoma
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- Sep 1998to Dec 2030
- How long will I take part?
- 5 Years
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include patients with solid tumours receiving systemic therapy for their disease who do not have other significant factors that affect the immune system
Who may be able to join
- Signed inform consent
- Histolgically verified solid tumour
- Receiving systemic therapy for neoplasm
- Has archival tumour tissue
- Provide biosamples with living tumour tissue or blood samples for immunologic assessment
Who cannot join
- Concurrent Lymphoprolipherative disorder
- Patients after stem cell or bone marrow thansplantation
- Incomplete informaton on previous cancer history or medical history
- Patients with known primary immunodeficiency
- Patients receiving immunosupressive therapy for concurrent illness
- Pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
N.N. Petrov NMRC of Oncology, Oncoimmunology dep.
Saint Petersburg, 197758
Aleksei Novik, MD, PhD, +78124399505, alexey.viktorovich.novik@gmail.com
About this study
Official title: Analysis of the Immunogenetic Profile of Patients With Aggressive Course of Malignant Neoplastic Process Resistant to the Standard Treatment Approaches: a Translational Study
The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. Possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies
- Conditions
- Malignant Solid Tumors, Primary Brain Tumor, Melanoma, Soft Tissue Sarcoma, Colorectal Cancer, Kidney Cancer
- Medical subject headings
- Brain Neoplasms, Melanoma, Sarcoma, Colorectal Neoplasms, Kidney Neoplasms, Prostatic Neoplasms
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 |
|---|---|---|
| Melanoma | Not described | |
| Soft tissue sarcoma | Not described | |
| Kidney cancer | Not described | |
| Primary brain tumors | Not described | |
| Malignant neoplasms | Not described | |
| Prostate cancer | Not described | |
| Colorectal cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression in 3 mo
Presence of disease progression within 3 mo from sample aquisition
Measured: 3 month
Secondary outcomes (3)
Overall survival (OS)
Time from sample aquisition to death from any reason
Measured: Up to 5 years
Progression free survival
Time from sample aquisition to progression or death from the disease
Measured: Up to 5 years
Response rate
Response assesmenr with RECIST 1.1 and iRECIST
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study startSep 1998
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irina Baldueva, MD, PhD, DSc, Study director, N.N. Petrov NMRC of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539677
- Sponsor's protocol ID
- AAAA-A18-118032890188-9
- Acronym
- REGATA
- Status last verified
- May 2024
- First submitted
- 4 Sep 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon completion, the database is planned to be published with depersonalized data for cohorts with meaningful data. Cohorts to be published will be defined upon data check. Partial publications could be applicable.
Publications
Shendaleva N, Novik AV, Zozulya A, Nekhaeva TL, Semenova A, Teletaeva GM, et al. Impact of the azoximer bromide concomitant therapy on patient outcomes in patients with melanoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;39(15_suppl):e21574-e.
Novik AV, Shendaleva N, Zozulya A, Nekhaeva TL, Semenova A, Teletaeva GM, et al. Impact of the azoximer bromide concomitant therapy on outcomes in patients with soft tissue sarcoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;39(15_suppl):e23534-e.
Novik AV, Girdyuk DV, Nekhaeva TL, Emelyanova NV, Semenova A, Teletaeva GM, et al. Progression prediction model for solid tumors with clinical and immunological parameters. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;39(15_suppl):2539.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Immunogenetic Profile of Patients With Aggressive Course of Malignant Neoplastic Process Resistant to the Standard Treatment Approaches: a Translational Study
- ClinicalTrials.gov ID
- NCT05539677
- Acronym / sponsor ID
- REGATA / AAAA-A18-118032890188-9
- Conditions
- Malignant Solid Tumors, Primary Brain Tumor, Melanoma, Soft Tissue Sarcoma, Colorectal Cancer, Kidney Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- Sep 1998 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 14 Sep 2022 (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.
The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. Possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Melanoma | – | – |
| Soft tissue sarcoma | – | – |
| Kidney cancer | – | – |
| Primary brain tumors | – | – |
| Malignant neoplasms | – | – |
| Prostate cancer | – | – |
| Colorectal cancer | – | – |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include patients with solid tumours receiving systemic therapy for their disease who do not have other significant factors that affect the immune system
Key inclusion criteria (5 listed)
- Signed inform consent
- Histolgically verified solid tumour
- Receiving systemic therapy for neoplasm
- Has archival tumour tissue
- Provide biosamples with living tumour tissue or blood samples for immunologic assessment
Key exclusion criteria (6 listed)
- Concurrent Lymphoprolipherative disorder
- Patients after stem cell or bone marrow thansplantation
- Incomplete informaton on previous cancer history or medical history
- Patients with known primary immunodeficiency
- Patients receiving immunosupressive therapy for concurrent illness
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
Progression in 3 mo
Time frame: 3 month
Presence of disease progression within 3 mo from sample aquisition
3 secondary outcomes
Overall survival (OS)
Time frame: Up to 5 years
Progression free survival
Time frame: Up to 5 years
Response rate
Time frame: During the intervention
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 6 May 2024.
- Results publicationShendaleva N, Novik AV, Zozulya A, Nekhaeva TL, Semenova A, Teletaeva GM, et al. Impact of the azoximer bromide concomitant therapy on patient outcomes in patients with melanoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;39(15_suppl):e21574-e.
- Results publicationNovik AV, Shendaleva N, Zozulya A, Nekhaeva TL, Semenova A, Teletaeva GM, et al. Impact of the azoximer bromide concomitant therapy on outcomes in patients with soft tissue sarcoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;39(15_suppl):e23534-e.
- Results publicationNovik AV, Girdyuk DV, Nekhaeva TL, Emelyanova NV, Semenova A, Teletaeva GM, et al. Progression prediction model for solid tumors with clinical and immunological parameters. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;39(15_suppl):2539.
- Individual participant dataSharing planned: Undecided. Upon completion, the database is planned to be published with depersonalized data for cohorts with meaningful data. Cohorts to be published will be defined upon data check. Partial publications could be applicable.
Related trials for Malignant Solid Tumors
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Irina Baldueva, MD, PhD, DSc study director
N.N. Petrov NMRC of Oncology
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 Malignant Solid Tumors and Primary Brain Tumor, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 5 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: looking for participants now, as of the sponsor's last update on 6 May 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 Russia. 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 Aleksei Novik, MD, PhD (+78124399505, alexey.viktorovich.novik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression in 3 mo (time frame: 3 month). 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 NCT05539677, which also lists 3 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 6 May 2024.