An observational study in Colorectal Cancer, Colorectal Adenoma and Gastric Cancer, sponsored by University of Latvia. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by University of Latvia · Observational
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Among 13 studies in Colorectal Neoplasms with a site in Latvia — 1 open to participants now, 2 under way, 1 of them phase 3. Colorectal Neoplasms · Latvia.
Among the 13 studies in Colorectal Neoplasms with a site in Latvia, this one is the only one that started in 2014, is one of 3 observational ones, and was the 8th registered.
6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.
Browse Colorectal Neoplasms studies →1 of the 13 studies in Colorectal Neoplasms with a site in Latvia is open now. Recruiting first, the newest first:
University of Latvia · Sites in Latvia
Ages 18+ · Healthy volunteers
A study can be open while its sites in Latvia have not opened yet or have stopped. Only those recruiting at a site in Latvia →
Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 7
First in 2006; this study’s year is marked. 1 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,022 is above the median of 250 across 1,442 observational studies indexed under Colorectal Neoplasms.
Median enrollment 430 across the 10 interventional studies, 3,000 across the 3 observational. Of the 10 that completed or were terminated, 6 (60%) have results posted.
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8 of 13 have an industry lead sponsor. The 9 most frequent:
University of Latvia is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
University of Latvia has 4 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Colorectal Neoplasms with a site in Latvia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon.
The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.
Patients with established disease (cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Lithuania). In addition, group of persons from general population at average risk for developing the target disease will be also enrolled.
Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) nanosensor technology.
Volunteers (including patients with established disease) will be enrolled prior the removal of the target lesion (e.g. surgery for cancer or polypectomy in the case of a polyp).
The study will be conducted by utilizing the experience of institutions in the European Union and Israel.
Cancer patients (Group 1 and 5) will be predominantly enrolled at the time scheduled for surgery, however also patients undergoing diagnostic procedures (endoscopy) will be eligible
Patients without malignant disease but defined colorectal (Groups 2-4) status will be predominantly enrolled prior colonoscopy in out-patient settings. Sampling starting from 1 week after colonoscopy will be allowed if the lesions will not get removed during the index endoscopy
Patients without malignant disease but defined gastric mucosal status (Groups 6-8) status will be predominantly enrolled prior upper endoscopy in out-patient settings. Sampling starting from 2 days after upper endoscopy will be allowed if the lesions will not get removed during the index endoscopy
Average cancer risk subjects (Group 9) will get enrolled by inviting individuals predominantly selected from the lists of general practitioners.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with histologically confirmed colorectal cancer (adenocarcinoma)
Procedure: Breath sampling for volatile marker detection · Procedure: Colonoscopy with biopsies or lesion removal when required · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition · Procedure: Histological evaluation of the surgery material
Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions.
Procedure: Breath sampling for volatile marker detection · Procedure: Colonoscopy with biopsies or lesion removal when required · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition
Patients without colorectal adenocarcinoma and without colorectal high-risk lesions as described under Group 2 criteria
Procedure: Breath sampling for volatile marker detection · Procedure: Colonoscopy with biopsies or lesion removal when required · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition
Patients having undergone colonoscopy without an evidence for colorectal lesions fulfilling Group 1 or Group 2 or Group 3 criteria. Prior to removal of the lesions.
Procedure: Breath sampling for volatile marker detection · Procedure: Colonoscopy with biopsies or lesion removal when required · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition
Patients with histologically confirmed gastric cancer (adenocarcinoma)
Procedure: Breath sampling for volatile marker detection · Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition · Procedure: Histological evaluation of the surgery material
Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach
Procedure: Breath sampling for volatile marker detection · Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition
Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, but excluding those with dysplasia (Group 5)
Procedure: Breath sampling for volatile marker detection · Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition
Staged 0-III according to OLGIM. Dysplasia should be excluded
Procedure: Breath sampling for volatile marker detection · Procedure: Upper endoscopy with biopsies · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition
Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer.
Procedure: Breath sampling for volatile marker detection · Procedure: Plasma/serum sampling · Procedure: Faecal sample acquisition
Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
The material obtained during surgery (stomach or colorectal) will be used for confirmation of the diagnosis in cancer groups. Surgery itself will be performed according to the clinical indications, and will not be extended (i.e. cannot be considered a study intervention)
Performance of nanoarray sensor testing to detect target lesions
Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
Time frame: At the time of breath sampling
VOCs differentiating the study groups
List of VOCs assayed by GC-MS with statistical difference between the study groups
Time frame: At the time of breath sampling
Identification of characteristic VOC pattern in risk age groups
List of characteristic VOCs in general population at risk for developing gastrointestinal cancer, including analysis of confounding factors, e.g. dietary habits, smoking, and profession.
Time frame: At the time of sampling
VOC pattern changes following treatment
Significant change in VOC content before and following treatment (surgery, medical therapy, combined)
Time frame: At baseline and every 6 months within 3 year period
Groups of gastrointestinal microbiota correlating to VOCs
List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs
Time frame: At the time of sampling
VOC pattern changes following intervention to microbiota
Significant change in VOC content before and following intervention upon microbiome (antibiotic intake, colon cleansing)
Time frame: At baseline and following the intervention (1 week, 1 month)
Gastric microbiome changes following intervention to microbiota
Significant change in gastric microbiome (phyla, genera) before and following intervention upon microbiome (antibiotic intake)
Time frame: At baseline and 3 years after intervention
Gastrointestinal microbiome in cancer patients
Significant differences in the composition of gastric and colonic microbiome (phyla, genera) in cancer patients, patients with precancerous lesions and controls
Time frame: At the time of sampling
The record gives a start of Jan 2014, a primary completion of Jun 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University of Latvia