Survival Monitoring in Russian Cancer Registries

Breast Cancer Clinical Trial

— SURVIMON  

Official title:

Survival Monitoring in Russian Cancer Registries

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06043947
• Other study ID #: SURVIMON-2023
• Status: Active, not recruiting
• Start date: August 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to establish a holistic framework for continuous cancer survival surveillance in Russian regions with high-quality population-based cancer registry data. The data from the population-based cancer registries of the Northwestern regions of Russia will be used to assess net and cause-specific survival trends.

Description:

The main sources of cancer incidence data in Russia are population-based cancer registries (PBCR). National recommendations guide the content of corresponding variables stored in PBCRs. Data were collected for the following regions: Arkhangelsk Oblast and Nenets Autonomous Okrug (combined), Republic of Karelia, Komi Republic, Vologda Oblast, Kaliningrad Oblast, Leningrad Oblast, Murmansk Oblast, Novgorod Oblast, Pskov Oblast, and St. Petersburg. Quality assessment procedures will be applied to the population-based cancer registries (PBCRs) datasets. Essential variables will be extracted following the recommended list of ENCR/IACR.

The list of variables consists of two classes: original variables present in PBCRs datasets and synthetic variables calculated based on the original variables. "IARC/IACR Tools for Cancer Registries" (IARC tools) software was used for the data cleaning, conversion to ICD-O-3, and multiple primaries assessment. Duplicates were removed by applying IARC/IACR/ENCR multiple primary rules. The analysis is limited to twenty years: 2000 - 2021.

The Federal State Statistics Service (FSSS) is the primary regional and national mortality data source. However, the raw data from this source has several drawbacks. The main problem is the absence of the distribution of persons with undetermined ages and/or causes of death. The data sets for this research are obtained from the Russian Fertility and Mortality Database (RFMD) of the Center for Demographic Research of the New Economic School. The RFMD database is based on the FSSS data but has a higher data quality due to the redistribution of deaths with the abovementioned characteristics. This source's population and mortality data contained the following variables: region, year, sex, age (5-year age groups from 0 to 85+), and cause of death.

Population data was obtained from the same source. The data were based on the 1989, 2002 and 2010 population censuses. It has been extrapolated to other years using annual statistics on mortality and births.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100000
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

Inclusion Criteria:

• Men and women of any age

• Data record meets IARC/IACR Tools for Cancer Registries requirements

Exclusion Criteria:

• Severe patient data missing from a record

Related Conditions & MeSH terms

• Breast Cancer
• Cervix Cancer
• Colon Cancer
• Lung Cancer
• Melanoma
• Oncology
• Prostate Cancer
• Survivorship
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Russian Federation	N. N. Petrov Research Institute of oncology	Saint-Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology	European University at St. Petersburg

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Barchuk A, Tursun-Zade R, Belayev A, Moore M, Komarov Y, Moshina N, Anttila A, Nevalainen J, Auvinen A, Ryzhov A, Znaor A. Comparability and validity of cancer registry data in the northwest of Russia. Acta Oncol. 2021 Oct;60(10):1264-1271. doi: 10.1080/0284186X.2021.1967443. Epub 2021 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net survival	Net survival computed using Pohar-Perme method.	From the date of diagnosis to the date of death (up to 10 years)
Primary	Cause-specific survival	Rates calculated using Kaplan-Maier method.	From the date of diagnosis to the date of death (up to 10 years)