China National Cancer Early Screening Trial: Lung and Colorectal Cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Lung And Colorectal Cancer
PROVIDER: 2686263 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: Group1:Annual LDCT and baseline colonoscopy;Group2:Biennual LDCT and annual FIT,those with positive FIT result will undergo colonoscopy
Primary outcome(s): Detection rate of suspected lung nodule;Early diagnosis rate of lung cancer;Detection rate of colorectal cancer;Detection rate of colorectal precancerous lesion;Early diagnosis rate of colorectal cancer;Cost-effectiveness
Study Design: Parallel
| 2682608 | ecrin-mdr-crc
Project description:This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).
The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
| 2199430 | ecrin-mdr-crc
Project description:Colorectal cancer (CRC) is currently the second most common cause of cancer death in the United States, and one of the most preventable cancers. It has been shown in several randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces CRC mortality by 13-33%. While there is strong consensus amongst experts regarding the value of CRC screening, the best approach to screening is not clear. Of the widely recommended modalities, FOBT and colonoscopy are the most commonly used within the United States. FOBT is inexpensive, non-invasive, and its use as a screening tool is supported by the highest quality evidence (i.e. randomized controlled trials). Moreover, newer FOBT, such as fecal immunochemical tests or FITs, have advantages over conventional FOBT in terms of both test characteristics and ease of use that make them quite attractive as a population-based screening tool.
While colonoscopy is invasive and has higher up-front risks and costs than FOBT, it does afford the opportunity to directly assess the colonic mucosa and is widely believed to be the best test to detect colorectal cancer. In addition, colonoscopy allows for the detection and removal of colorectal adenomas -a well recognized colorectal cancer precursor. There is indirect evidence that suggests colonoscopy is effective in reducing colorectal cancer mortality, but to date, no large clinical trials have been completed to support this assumption. While colonoscopy use is increasing, data is emerging that colonoscopy may not be as effective as previously believed. Prior support for colonoscopy as a screening test relied upon effectiveness estimates that now appear to be overly optimistic. Given the invasive nature of colonoscopy, the associated small, but real risk of complications, and dramatically higher costs than other screening tests, it is especially important to determine the true comparative effectiveness of colonoscopy relative to other proven non-invasive options.
The investigators propose to perform a, large, simple, multicenter, randomized, parallel group trial directly comparing screening colonoscopy with annual FIT screening in average risk individuals. The hypothesis is that colonoscopy will be superior to FIT in the prevention of colorectal cancer mortality measured over 10 years. Individuals will be enrolled if they are currently eligible for CRC screening (e.g. no colonoscopy in the past 10 years and no FOBT in the past 1 year) and are between 50 and 75 years of age. The investigators will exclude individuals for whom colonoscopy is indicated (e.g. signs or symptoms of CRC, first degree family member with CRC, personal history of colorectal neoplasia or inflammatory bowel disease).
All participants will complete baseline demographic, medication, and lifestyle questionnaires (e.g. diet, non-steroidal anti-inflammatory use, frequency of exercise) prior to randomization in a 1:1 ratio to either screening colonoscopy or annual FIT screening (Figure 1). Those testing positive by FIT will undergo evaluation to determine appropriateness for colonoscopy. Screening will be performed in a manner consistent with the currently accepted standard of care in order to determine the comparative effectiveness of the two screening strategies. Participants will be surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC.
The primary study endpoint will be CRC mortality within 10 years of enrollment. The secondary endpoints are (1) the incidence of CRC within 10 years of enrollment and (2) major complications of colonoscopy. Mortality will be determined through queries of the VA Vital Status File. Cause of death will be determined primarily using death certificates from the National Death Index-Plus database, augmented by adjudication of medical records for known CRC cases where CRC is not listed as a cause of death on the death certificate. The investigators postulate that screening colonoscopy will result in a 40% reduction in CRC mortality over 10 years relative to annual FIT screening. Using a log-rank test with a 2-sided test of significance, =0.05, a sample size of 50,000 participants will be required to test the primary hypothesis with 82% power, assuming a 1% annual rate of crossover from FIT to colonoscopy and a 0.5% annual rate of loss to follow-up. The planned study duration is 12.5 years with 2.5 years of recruitment and 10 years of follow-up for all enrolled participants.
| 2097935 | ecrin-mdr-crc
Project description:Gene expression alterations in response to cigarette smoke have been characterized in normal-appearing bronchial epithelium of healthy smokers and it has been suggested that adjacent histologically normal tissue display tumor-associated molecular abnormalities. We sought to delineate the spatial and temporal molecular lung field of injury in smoker early stage non-small cell lung cancer (NSCLC) patients (n=19) who were accrued into a surveillance clinical trial for annual follow-up and bronchoscopies within one year after definitive surgery.
2012-12-01 | GSE40407 | GEO
Project description:Gene expression alterations in response to cigarette smoke have been characterized in normal-appearing bronchial epithelium of healthy smokers and it has been suggested that adjacent histologically normal tissue display tumor-associated molecular abnormalities. We sought to delineate the spatial and temporal molecular lung field of injury in smoker early stage non-small cell lung cancer (NSCLC) patients (n=19) who were accrued into a surveillance clinical trial for annual follow-up and bronchoscopies within one year after definitive surgery. Bronchial brushings and biopsies were obtained from six different sites in the lung at the time of inclusion in the study and at 12, 24 and 36 months after the first time point. Affymetrix Human Gene 1.0 ST arrays were used for whole-transcript expression profiling of airways (n=391). Mixed-effects models were performed to determine significant differential gene expression modulation by site from tumor and time following inclusion in the study within the molecular field of injury.
2012-12-01 | E-GEOD-40407 | biostudies-arrayexpress
Project description:This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 70-82 with a history of colorectal polyps who are due for surveillance colonoscopy.
| 2761012 | ecrin-mdr-crc
Project description:Acute Respiratory Distress Syndrome (ARDS) is a very common clinical entity and a major cause of morbidity and mortality in the critical care setting. Historically, ARDS has been associated with mortality ranging from 40% to 60% . In the US alone,200,000 new cases of ARDS occur every year. ARDS can be associated with different clinical disorders affecting the lungs. A novel ex-vivo swine model developed by our group permits measurements of lung pathophysiology and simultaneous collection of lung and liver tissue for histologic and molecular comparisons during the early phase of the response to endotoxemia. In this preparation, endotoxemia causes a liver-dependent inflammatory response and severe lung injury and dysfunction. We chose swine, as an experimental animal because, like humans, they are especially sensitive to endotoxin and the pathophysiology of the response appears to be similar to that in humans. Gene expression was evaluated in swine liver before and after endotoxin treatment.
2013-01-10 | E-MTAB-1436 | biostudies-arrayexpress
Project description:The investigators will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). In the proposed 2-arm study, both PRIME-CRC and enhanced usual care (control) will incorporate health literacy evidence-based practices for delivering CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy, including simplified test instructions. In addition, the PRIME-CRC arm will use a "stepped care" approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will receive frequent follow-up contact from their health care provider via audio-recorded, automated call or SMS text, based on patient preference.
| 2333453 | ecrin-mdr-crc
Project description:Whole blood was collected as part of annual health assessments of beluga whales from the healthy Bristol Bay, Alaska stock during 2012-2014. Gene expression from 24 animals (8 from each year) was analyzed to establish baseline information on the content and variation of the beluga whale blood transcriptome.
2017-05-11 | GSE98735 | GEO
Project description:Lung cancer is the uncontrolled growth of abnormal cells in the lungs, which can form tumors and interfere with the functioning of the lung. This disease is registered worldwide as the most common type of cancer in men as well as the most common cause of death; besides lung cancer mortality in women has experienced a significant increase in recent years. In Mexico, lung cancer was recorded as the leading cause of death, representing 9.7% of the total annual cancer deaths. Small Cell Lung Cancer (SCLC) is a malignant epithelial tumor classified as a high-grade neuroendocrine carcinoma tumor that usually occurs in the central airways4 with high growth rate and early development of metastases. The classic treatments used to treat this type of pathologies are radiotherapies, chemotherapies, and surgeries that tend to be ineffective and with side effects that lead patients' quality of life to low levels. Due to this lack of effectiveness of classic therapies, we are looking for alternative therapies that may be more effective and hopeful for cancer patients; especially those treatments based on the use of nanomedicine. The objective of this work was to use Label-free based DIA approach to evaluate the differences in the proteome of enriched membranes between a SCLC cell line H69AR (ATCC® CRL-11351) and a non-tumoral lung cell line MRC5 (ATCC® CCL171), and additionally, compare which protein receptors are overexpressed in cancer vs normal cells, in this way we can select the best target for functionalization of core-shell nanoparticles (CSNPs) to improve the affinity of the therapy for the cancer cell instead of normal cell, this in order to decrease the negative effects of chemotherapeutic drugs in healthy cells.
2022-08-19 | PXD015405 | Pride