Colorectal cancer (CRC) incidence and mortality are rapidly rising in sub-Saharan Africa; CRC is now the 4th most common cancer in the World Health Organization-Africa region. This rising burden is mirrored in Nigeria, where more than half of the patients die within one year of diagnosis. These statistics highlight the need for cost effective, evidence-based prevention, screening and treatment interventions in this limited-resource region.m
Prospective collection and banking of colorectal cancer specimens and database containing clinical information -ARGO has built a large prospective colorectal cancer database in sub-Saharan Africa as well as a biobank to store specimens. This will facilitate the development of prevention, treatment, and Cancer control plans. There are two -80 freezers housed at OAU that hold specimens.
NIH-funded UG3/UH3 study of a point-of-care urine-based screening test for CRC, which includes three Nigeria sites (Ilorin, Ibadan, OAUTHC) – This is a-two phase study. Phase 1 will adapt a 3-metabolite biosensor that identifies patients with colorectal cancer (CRC) and precancerous polyps to Nigerian patients. Phase 2 will pilot test and evaluate the point-of-care (POC) biosensor device in Nigeria.
In Phase 1, urine will be collected from 450 Nigerian patients (150 with CRC, 150 with polyps, and 150 patients with no colon premalignant or malignant pathology). We will use these samples to refine a handheld biosensor. This handheld biosensor is intended to be a cost effective POC diagnostic test highly sensitive for CRC in Nigerian patients.
In Phase 2, we will pilot test the biosensor device in Nigeria with 75 patients that are high-risk for CRC. We will then use the POC test in real-time on urine from 645 patients who are in one of three groups:
> 40 years of age with rectal bleeding;
a family history of CRC;
have a history of CRC but currently have no evidence of disease.
All patients will receive a colonoscopy. We anticipate study completion within 5 years.
Study of fecal immunochemical testing (FIT) in the Nigerian population – This multicenter prospective study seeks to evaluate the efficacy of the fecal immunochemical test (FIT) for hemoglobin as a CRC screening tool in 2 distinct Nigerian cohorts: high-risk individuals with a first-degree relative with CRC (n=100) and average-risk individuals 50-75 years of age (n=1000). The high-risk cohort will be identified using the African Research Group for Oncology (ARGO), prospective, CRC database. An interview-administered questionnaire will capture socio-demographic variables from eligible study participants.
Participants will be given a package containing a FIT kit and given information on colorectal symptoms and risk factors. 48-hours after enrollment, participants will return with their stool specimens. FIT kits will be immediately processed by research staff, while the participants are completing a short questionnaire. All high-risk individuals will undergo colonoscopy, regardless of FIT result; whereas only average-risk participants with a FIT-positive result will also undergo follow-up colonoscopy. All participants who undergo colonoscopy will receive a follow-up questionnaire.
R01: Determining the risk factor profile and biology of colorectal cancer in Nigeria – This study will leverage existing collaborations and ARGO infrastructure to: 1) Determine the unique genomic profile of CRC in Nigeria. We will perform targeted deep sequencing of 468 established cancer genes in 360 matched tumor and blood samples from Nigerian CRC patients to identify somatic and germline mutations. We will compare our data to existing datasets, including the MSK tumor sequencing cohort as well as publicly available data in The Cancer Genome Atlas to define the unique genetic landscape of Nigerian CRC. 2) Identify the modifiable risk factor profile of CRC in Nigeria.
We will perform a case-control study to identify CRC risk factors in Nigeria. The 360 CRC patients from Aim 1 and an additional 240 CRC patients will be accrued and matched to 1,200 cancer-free population-based controls. Participants will complete an existing questionnaire to assess demographic, anthropometric, reproductive, lifestyle, diet, and medical history. Through these studies, we will obtain an understanding of the genetic and modifiable risk factors associated with CRC in Nigeria, information that can be used to inform a multi-pronged prevention, screening, and therapeutic approach to counter the rapidly rising CRC morbidity and mortality in this region.
Microbiome study in Nigerian patients with CRC – To describe the gut microbiome community diversity of a cohort of community dwelling Nigerians and compare with CRC patients in Nigeria and at MSK. We will collect stool for microbiome and metabolomic analysis from community dwelling persons in the catchment area of ARGO facilities in Nigeria while contemporaneously administering an extensive medical and environmental exposure questionnaire. Stool specimens will undergo routine evaluation for parasite co-infection, a known modulator of gut flora composition and human immune response.