The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Survival Monitoring in Russian Cancer Registries (SURVIMON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06043947
Recruitment Status : Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : October 16, 2023
Sponsor:
Collaborator:
European University at St. Petersburg
Information provided by (Responsible Party):
N.N. Petrov National Medical Research Center of Oncology

Brief 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.

Condition or disease
Melanoma Breast Cancer Oncology Colon Cancer Prostate Cancer Survivorship Lung Cancer Cervix Cancer

Detailed 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Survival Monitoring in Russian Cancer Registries
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma




Primary Outcome Measures :
  1. Net survival [ Time Frame: From the date of diagnosis to the date of death (up to 10 years) ]
    Net survival computed using Pohar-Perme method.

  2. Cause-specific survival [ Time Frame: From the date of diagnosis to the date of death (up to 10 years) ]
    Rates calculated using Kaplan-Maier method.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   0 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patient population, that were diagnosed and registered in regions covered by PBCR.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043947


Locations
Layout table for location information
Russian Federation
N. N. Petrov Research Institute of oncology
Saint-Petersburg, Russian Federation, 197758
Sponsors and Collaborators
N.N. Petrov National Medical Research Center of Oncology
European University at St. Petersburg
Publications:
Layout table for additonal information
Responsible Party: N.N. Petrov National Medical Research Center of Oncology
ClinicalTrials.gov Identifier: NCT06043947    
Other Study ID Numbers: SURVIMON-2023
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: October 16, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by N.N. Petrov National Medical Research Center of Oncology:
Survivorship survey
Survivorship care
Oncology
Melanoma
Breast cancer
Lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Uterine Cervical Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Urogenital Neoplasms
Genital Diseases
Urogenital Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications