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Final Progress Reports: Northeastern University: Human Subjects and Sampling Core

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Superfund Research Program

Human Subjects and Sampling Core

Project Leader: Jose F. Cordero (University of Georgia)
Co-Investigator: Carmen Milagros Velez Vega (University of Puerto Rico Medical Sciences Campus)
Grant Number: P42ES017198
Funding Period: 2010-2025
View this project in the NIH Research Portfolio Online Reporting Tools (RePORT)

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Final Progress Reports

Year:   2019  2013 

Studies and Results

The infrastructure for recruitment of follow-up of pregnant women in the north Karst region of Puerto Rico is operating efficiently. Through December 31, 2013, a total of 1004 potential study subjects were screened at 7 recruitment sites, 793 met eligibility requirements, 653 (82%) study subjects were enrolled, 361 have completed pregnancy (332 live births, 29 other pregnancy outcomes), and there are 292 participants currently being followed. Of the live births, 290 were full term births and 42 were preterm births (14.5%). There have been 134 withdrawals at different times during follow up. The Human Subjects and Sampling Core is fully staffed with 3 nurses, 1 physician, and 7 students. Five clinical laboratories at recruitment sites collect blood samples and the research lab is processing, managing and shipping samples. The 80°F freezer is operational and being filled with samples. The FreezerPro software was installed and is being used for barcoding and tracking samples. An MOU was signed with the Puerto Rico Clinical Translation Research Consortium (PRCTRC) to serve as a backup laboratory for storage and processing of samples in case of an emergency. The PRCTRC is also providing transportation to recruitment sites for the study staff.

A total of 1004 potential study subjects were administered the screening questionnaire. 501 participants have completed Visit 1 questionnaires, 443 have had the home visit, and 413 have completed the Visit 3 questionnaires. In addition, data abstractions of the medical record were conducted together with each visit.

The following biological samples were obtained through December 31, 2013:

  • Visit 1: 501 subjects. These samples include venous blood for metals (3 ml), PAX gene (8.5 ml), 2 tubes for red blood cells (17.5 ml), and plasma (8.5 ml). A urine sample (50 to 100 ml) is also included.
  • Visit 2: 443 subjects. These samples include urine and hair samples (about 100 strands).
  • Visit 3: 413 subjects. Each subject samples include venous blood for metal (3 ml), 2 tubes for red blood cells (17.5 ml), and plasma (8.5 ml). It also includes a urine sample (50 to 100 ml).

Five clinical laboratories at recruitment sites are collecting and processing blood samples. The transport system for biological samples from local lab to the Medical Sciences Campus Lab is operational. All staff involved in biological samples handling completed the required biosafety course. Lab staff completed the required shipping course. The purchased freezer is operational and holding study samples. The barcoding and sample management software was installed and operational. The software FreezerPro2011 provides multisite access to the system for tracking and management of samples.

The Human Subjects and Sampling Core collaborates with the Data Management and Modeling Core. Data entry using RedCap is operational and data has been entered for all the completed questionnaires and data entry form. The data incorporated into the Data Core presently includes 3,552 total fields/participant representing data collected from 14 different forms. All newly completed questionnaires are entered and verified into RedCap within 5 working days.

Significance

The Human Subjects and Sampling Core team has made important progress in developing the infrastructure to conduct recruit and retain pregnant women in Puerto Rico through completion of pregnancy, acquired data, obtain biological samples and process them to support PROTECT research objectives.

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