Colorectal Cancer Clinical Trial
Official title:
A Prospective Colonoscopic Study to Investigate Risk of Colorectal Neoplasms in First-degree Relatives of Patients With Non-advanced Adenomas (NonAA Study)
The risk of CRC in families of patients with CRC is well established, but it is less
well-defined for families of patients with adenomas. Screening recommendations to families
when an index subject has an adenoma on colonoscopy are not clear. Previous studies
demonstrating an increased CRC risk in close relatives of subjects with adenomas were mostly
limited by the lack of a suitable comparison group, did not offer colonoscopy to all
relatives or did not have verification on true status of adenoma history in the relatives. A
systematic review has reported that most studies cited for risk of CRC in relatives with
adenomas have not addressed the intended question. Currently International guidelines
recommended screening colonoscopy in close relatives and at a younger age when there is a
proband with an adenoma, however this recommendation has not been fully supported by all
societies due to the lack of robust evidence. This gap in knowledge highlights the need of
well-designed and adequately powered studies to estimate the risk of colorectal neoplasms in
subjects who have first-degree relatives with adenomas.
Up to 30% of average risk asymptomatic individuals 50 years or older will have at least one
adenoma. Based on current guidelines, nearly half the population will be counseled to undergo
a colonoscopy from 40 years old based on a positive family history of adenoma. This will have
enormous burden on the healthcare system if screening is implicated in all these individuals.
Secondly, not all adenomas carry the same risk. Large or villous adenomas are associated with
a nearly 70% increased risk of CRC in first degree relatives (FDR) whereas small adenomas may
be associated with a modest increased risk 19. It is therefore important to determine the
risk of colorectal neoplasms in families of subjects with non-advanced adenomas to justify
more intensive screening in these individuals. Investigators hypothesize that first-degree
relatives of patients with non-advanced adenoma have an increased risk of both CRC and
adenomas. Investigators aim to quantify this risk, and to identify other individual patient
or neoplasm characteristics that may contribute to this increased risk. In addition,
Investigators aim to determine molecular alteration profiles of colonic adenoma in siblings
of patients with advanced neoplasm.
Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer
death worldwide. Based on data from the Hong Kong Cancer Registry in 2012, CRC is the second
most common cancer in Hong Kong. It is one of the few cancers for which there are convincing
data to support the benefits of screeColorectal cancer (CRC) is the third most common cancer
and second leading cause of cancer death worldwide. Based on data from the Hong Kong Cancer
Registry in 2012, CRC is the second most common cancer in Hong Kong. It is one of the few
cancers for which there are convincing data to support the benefits of screening. Currently
the removal of adenomas is the most effective way in reducing cancer incidence and mortality.
International guidelines recommend screening for individuals at an average risk of CRC from
the age of 50 years.
Up to 30% of average risk asymptomatic individuals 50 years or older will have at least one
adenoma. Based on current guidelines, nearly half the population will be counseled to undergo
a colonoscopy from 40 years old based on a positive family history of adenoma. This will have
enormous burden on the healthcare system if screening is implicated in all these individuals.
Secondly, not all adenomas carry the same risk. Large or villous adenomas are associated with
a nearly 70% increased risk of CRC in first degree relatives (FDR) whereas small adenomas may
be associated with a modest increased risk. It is therefore important to determine the risk
of colorectal neoplasms in families of subjects with non-advanced adenomas to justify more
intensive screening in these individuals.
The molecular pathways leading to tumour development in familial colorectal neoplasms are
likely to be different from sporadic cases. Development of new molecular based methods for
early detection, prevention or treatment relies heavily on the understanding of the
differences between sporadic and familial neoplasms. Identification of genetic mutations can
also improve genetic diagnosis and screening protocol of an at risk population.
Investigators hypothesize that first-degree relatives of patients with non-advanced adenoma
have an increased risk of both CRC and adenomas. Investigators aim to quantify this risk, and
to identify other individual patient or neoplasm characteristics that may contribute to this
increased risk. In addition, Investigators aim to determine molecular alteration profiles of
colonic adenoma in siblings of patients with advanced neoplasm.
The risk of CRC in families of patients with CRC is well established, but it is less
well-defined for families of patients with adenomas. Screening recommendations to families
when an index subject has an adenoma on colonoscopy are not clear. Previous studies
demonstrating an increased CRC risk in close relatives of subjects with adenomas were mostly
limited by the lack of a suitable comparison group, did not offer colonoscopy to all
relatives or did not have verification on true status of adenoma history in the relatives. A
systematic review has reported that most studies cited for risk of CRC in relatives with
adenomas have not addressed the intended question. Currently International guidelines
recommended screening colonoscopy in close relatives and at a younger age when there is a
proband with an adenoma, however this recommendation has not been fully supported by all
societies due to the lack of robust evidence. This gap in knowledge highlights the need of
well-designed and adequately powered studies to estimate the risk of colorectal neoplasms in
subjects who have first-degree relatives with adenomas.
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