Colorectal CancerPURIFICARNCT00927680
Familial Colorectal Cancer Registry in Hispanics
An observational study of Colorectal Cancer and Gastric Cancer, run by University of Puerto Rico at 2 sites in Puerto Rico.
Trial summary
Colorectal cancer (CRC) is the second leading cause of cancer in Puerto Rico (PR) accounting for approximately 1,500 individuals annually, which represent 12% of all cancer cases in the island. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer, Colorectal Neoplasms
- How many people
- 5,000 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- Jul 2007to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Probands will be ascertained from the Puerto Rico Central Cancer Registry (PRCCR), from the monthly report of incident colorectal cancer cases. Eligible cases were persons (1) with pathologic diagnosis of colorectal cancer; (2) who were 15 years of age or older, and (3) without previous history of colorectal cancer. 2. Probands will be ascertained from the Oncology Hospital, UDH Hospital and the Ashford Presbyterian Community Hospital.
Who may be able to join
- patients with colon polyps or colon cancer
- patients will have a colonoscopy or colon surgery to treat a benign condition such as fissure, fistula, or hemorrhoids
Who cannot join
- Participation in this study is limited to persons 15 years or older with colon polyps or colon cancer and control subjects 21 years or older with no malignant conditions in the colon and / or rectum. Controls between the ages of 15 to 20 years will be not evaluated. The reason is colon cancer occurs in people under 21 years, except in special cases associated with certain genetic causes. People who cannot sign the consent may not participate in this study.
Trial locations and contacts
2 sites in 1 country.
Puerto Rico2 sites, 2 recruiting
- Recruiting
Oncologic Hospital
San Juan, PR, 00911
Jessica Hernandez, RN, MS
- Recruiting
University of Puerto Rico Comprehensive Cancer Center
San Juan, 00936
Marcia R. Cruz-Correa, MD, PhD, 787-772-8300 ext. 1221, marcia.cruz1@upr.edu
Jessica Hernandez, RN, BS, MS, 787-772-8300, Jessica.hernandez8@upr.edu
About this study
Official title: Familial Colorectal Cancer In Puerto Rico: A Feasibility Study
Colorectal cancer (CRC) is the second leading cause of cancer in Puerto Rico (PR) accounting for approximately 1,500 individuals annually, which represent 12% of all cancer cases in the island. The genetic epidemiology of CRC among Hispanic populations is not well studied, hence studies focused on large, well defined ethnic groups such as Puerto Ricans, are clearly warranted. The first step towards evaluating the molecular, environmental, and genetic epidemiology of CRC in PR is to establish a population-based familial CRC registry. The following specific aims have been proposed:
Specific Aim 1: To prospectively identify and recruit approximately 300 CRC probands from two distinct geographical areas in PR (Metropolitan and Southern Region). From each proband the investigators will obtain a pedigree extended to second-degree relatives and cousins. Assuming 10% will be positive for a family history of CRC, the investigators will then recruit all 30 probands with a family history of CRC and a sample of 15 family-history negative probands and obtain: paraffin-embedded tumors blocks, blood samples, risk factor and food frequency questionnaires.
Read more
Specific Aim 2: To prospectively identify and recruit selected relatives (parents, grandparents, and same generation relatives - cousins and siblings) from the 45 probands identified in Specific Aim 1. In addition, for siblings and cousins of probands (i.e. relatives in the same generation as the proband), the investigators will obtain risk factor and food frequency questionnaires, and for colorectal cancer cases, tumor blocks and pathology reports of their cancers.
Specific Aim 3: To estimate from this pilot study the following parameters: (a) response rate of probands and their selected relatives; (b) response rate of participants for each data item; (c) family history of CRC and other cancers; (d) number of living first- and second-degree relatives and cousins of probands; (e) number of these relatives who live in the same household and region/municipality; (f) prevalence/distribution of selected risk factors from the administered questionnaires.
Read the detailed description
Data obtained from this study will serve as the foundation for our large, island-wide, population-based, genetic-epidemiologic study of familial colorectal cancer in Puerto Rico. Through this feasibility study, we will assess the feasibility: (1) of recruiting colorectal cancer patients using the PR Central Cancer Registry, (2) of evaluating family pedigrees and recruiting the relatives of probands (3) obtaining tumor, blood, medical and exposure information from both probands and their relatives. Providing important data on Hispanic populations that would enable family-based case-control studies of risk factors for CRC, with an emphasis on candidate genes in selected carcinogenic pathways, genetic and epigenetic modifications. Furthermore, information obtained from this proposal may serve to identify families that would be informative for linkage studies to potentially map new genes, evaluate genotype-phenotype correlations, gene-gene and gene-environmental interactions.
- Conditions
- Colorectal Cancer, Gastric Cancer, Colorectal Neoplasms, Colorectal Adenoma, Lynch Syndrome
- Keywords
- Colorectal Cancer, Familial Colorectal Cancer, Genetics, Hispanics, Lynch Syndrome
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer cases | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will recruit individuals with colorectal cancer with and without family history of CRC and their immediate family members and obtain the following: paraffin-embedded tumors blocks, blood samples, risk factor and food frequency questionnaires.
Measured: 10 years
Secondary outcomes (1)
We will study the following parameters that we help us plan the larger population-based study such as: response rate of probands and their selected relatives, response rate of participants (probands and relatives), etcetera.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico
- Investigators
- Marcia R. Cruz-Correa, MD, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927680
- Sponsor's protocol ID
- R03CA130034 NCI
- Other IDs
- R03CA130034
- Acronym
- PURIFICAR
- Status last verified
- Nov 2020
- First submitted
- 24 Jun 2009
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Colorectal Cancer In Puerto Rico: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00927680
- Acronym / sponsor ID
- PURIFICAR / R03CA130034 NCI
- Conditions
- Colorectal Cancer, Gastric Cancer, Colorectal Neoplasms, Colorectal Adenoma, Lynch Syndrome
- Keywords
- Colorectal Cancer, Familial Colorectal Cancer, Genetics, Hispanics, Lynch Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer (CRC) is the second leading cause of cancer in Puerto Rico (PR) accounting for approximately 1,500 individuals annually, which represent 12% of all cancer cases in the island. The genetic epidemiology of CRC among Hispanic populations is not well studied, hence studies focused on large, well defined ethnic groups such as Puerto Ricans, are clearly warranted. The first step towards evaluating the molecular, environmental, and genetic epidemiology of CRC in PR is to establish a population-based familial CRC registry. The following specific aims have been proposed:
Specific Aim 1: To prospectively identify and recruit approximately 300 CRC probands from two distinct geographical areas in PR (Metropolitan and Southern Region). From each proband the investigators will obtain a pedigree extended to second-degree relatives and cousins. Assuming 10% will be positive for a family history of CRC, the investigators will then recruit all 30 probands with a family history of CRC and a sample of 15 family-history negative probands and obtain: paraffin-embedded tumors blocks, blood samples, risk factor and food frequency questionnaires.
Specific Aim 2: To prospectively identify and recruit selected relatives (parents, grandparents, and same generation relatives - cousins and siblings) from the 45 probands identified in Specific Aim 1. In addition, for siblings and cousins of probands (i.e. relatives in the same generation as the proband), the investigators will obtain risk factor and food frequency questionnaires, and for colorectal cancer cases, tumor blocks and pathology reports of their cancers.
Specific Aim 3: To estimate from this pilot study the following parameters: (a) response rate of probands and their selected relatives; (b) response rate of participants for each data item; (c) family history of CRC and other cancers; (d) number of living first- and second-degree relatives and cousins of probands; (e) number of these relatives who live in the same household and region/municipality; (f) prevalence/distribution of selected risk factors from the administered questionnaires.
Detailed description
Data obtained from this study will serve as the foundation for our large, island-wide, population-based, genetic-epidemiologic study of familial colorectal cancer in Puerto Rico. Through this feasibility study, we will assess the feasibility: (1) of recruiting colorectal cancer patients using the PR Central Cancer Registry, (2) of evaluating family pedigrees and recruiting the relatives of probands (3) obtaining tumor, blood, medical and exposure information from both probands and their relatives. Providing important data on Hispanic populations that would enable family-based case-control studies of risk factors for CRC, with an emphasis on candidate genes in selected carcinogenic pathways, genetic and epigenetic modifications. Furthermore, information obtained from this proposal may serve to identify families that would be informative for linkage studies to potentially map new genes, evaluate genotype-phenotype correlations, gene-gene and gene-environmental interactions.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer cases | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Probands will be ascertained from the Puerto Rico Central Cancer Registry (PRCCR), from the monthly report of incident colorectal cancer cases. Eligible cases were persons (1) with pathologic diagnosis of colorectal cancer; (2) who were 15 years of age or older, and (3) without previous history of colorectal cancer. 2. Probands will be ascertained from the Oncology Hospital, UDH Hospital and the Ashford Presbyterian Community Hospital.
Key inclusion criteria (2 listed)
- patients with colon polyps or colon cancer
- patients will have a colonoscopy or colon surgery to treat a benign condition such as fissure, fistula, or hemorrhoids
Key exclusion criteria (1 listed)
- Participation in this study is limited to persons 15 years or older with colon polyps or colon cancer and control subjects 21 years or older with no malignant conditions in the colon and / or rectum. Controls between the ages of 15 to 20 years will be not evaluated. The reason is colon cancer occurs in people under 21 years, except in special cases associated with certain genetic causes. People who cannot sign the consent may not participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We will recruit individuals with colorectal cancer with and without family history of CRC and their immediate family members and obtain the following: paraffin-embedded tumors blocks, blood samples, risk factor and food frequency questionnaires.
Time frame: 10 years
1 secondary outcome
We will study the following parameters that we help us plan the larger population-based study such as: response rate of probands and their selected relatives, response rate of participants (probands and relatives), etcetera.
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia R. Cruz-Correa, MD, PhD principal investigator
University of Puerto Rico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Gastric Cancer, run by University of Puerto Rico at 2 sites in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcia R. Cruz-Correa, MD, PhD (787-772-8300 ext. 1221, marcia.cruz1@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will recruit individuals with colorectal cancer with and without family history of CRC and their immediate family members and obtain the following: paraffin-embedded tumors blocks, blood samples, risk factor and food frequency questionnaires. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.