Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613230
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Improved Early Diagnosis in Female Pelvic Cancer With OC Detect
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improved Early Diagnosis and Survival in Female Pelvic Cancer eg Ovarian Cancer With OC Detect Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn if so called Volatile Organic Compounds VOCs in blood can be used for early diagnosis of ovarian cancer The main question it aims to answer is
Can OC Detect a new in vitro diagnostic instrument distinguish between VOC patterns in blood plasma from women with ovarian cancer especially in early stage and VOC patterns in helthy women Participants are previosuly diagnosed patients with ovarian cancer who agreed to store their blood samples in biobanks for future medical research purposes Healthy female blood donors serve as benign control blood samples
Can OC Detect a new in vitro diagnostic instrument distinguish between VOC patterns in blood plasma from women with ovarian cancer especially in early stage and VOC patterns in helthy women Participants are previosuly diagnosed patients with ovarian cancer who agreed to store their blood samples in biobanks for future medical research purposes Healthy female blood donors serve as benign control blood samples
Detailed Description:
Pelvic Endometrial and Ovarian cancer ovarian-tubal-peritoneal cancer is the sixth and seventh most frequent type of cancer and ovarian cancer the fourth leading cause of cancer related death among Swedish women Endometrial cancer gives mostly early symptoms but two thirds of patients with ovarian cancer are diagnosed with advanced stage of the disease and this is reflected in poor outcome Early diagnosis is challenging especially in ovarian cancer
Plasma protein biomarker panels with improved diagnostic performance and predicting survival in patients with ovarian tumors have been performed by several research groups The sensitivity is good but specificity is today not good enough for screening purposes Several blood-based protein biomarker candidates for endometrial cancer detection have been reported but the protein biomarkers have so far only clinical relevance in advanced or recurrent endometrial cancers However there is a need for improved more specific broader biomarker panels for discrimination between localized or metastatic disease and preoperative risk stratification especially in endometrial cancer patients Such improved biomarker panels would be able to predict metastatic disease and guide adjuvant chemotherapy treatment
Endogenous volatile organic compounds VOCs are products of metabolic activity in the body and changes to these VOCs can be characteristic of specific disease processes such as cancer development Analyses in plasma of VOCs such as triethylamine pyridine toluene etc with Field-Effect-Transistor FET -based gas sensors have shown to be able to measure VOCs very accurately in low concentrations Bastuck thesis 2009 The metabolism in cancer cells vastly differs from that of healthy cells Elevated glycolysis leads to increases in lactate and fumarate metabolites resulting in altered VOC abundances in exhaled breath Experimental data indicate that the detection of VOCs released by various cancer cells may be useful in early diagnoses of cancer In patients with ovarian cancer analyzes of specific VOC s in blood has shown promising results to discriminate patient with ovarian cancer from healthy women Horvath The investigators have very recently in 37 patients out 38 with ovarian cancer found VOC indicating cancer which indicates a preliminary sensitivity of 97 In the total material of 68 analyzed samples 3 false positive results were found which indicates a specificity of 90 In a population with 1 malignancy the positive predictive value would be almost 10 and negative predictive value 999
In the current study samples from more ovarian cancer patients will be included and also samples from patients with other cancer types totally 245 patients of which 50 ovarian cancers The aim will be to see if good sensitivity and specificity can be achived with larger patient population same or better values than in the previous study Special focus will be put on early stages of ovarian cancer as well as borderline tumours The investigators aim also to see how distinct is VOC pattern for ovarian cancer compared to the VOC patterns for the other cancer forms Finally the study will give preliminary answer if VOC patterns for the other types of cancer ie breast colorectal bladder endometrie cervix is specific so it could be used in the future for development of dedicated diagnostic tools for those diseases
Plasma protein biomarker panels with improved diagnostic performance and predicting survival in patients with ovarian tumors have been performed by several research groups The sensitivity is good but specificity is today not good enough for screening purposes Several blood-based protein biomarker candidates for endometrial cancer detection have been reported but the protein biomarkers have so far only clinical relevance in advanced or recurrent endometrial cancers However there is a need for improved more specific broader biomarker panels for discrimination between localized or metastatic disease and preoperative risk stratification especially in endometrial cancer patients Such improved biomarker panels would be able to predict metastatic disease and guide adjuvant chemotherapy treatment
Endogenous volatile organic compounds VOCs are products of metabolic activity in the body and changes to these VOCs can be characteristic of specific disease processes such as cancer development Analyses in plasma of VOCs such as triethylamine pyridine toluene etc with Field-Effect-Transistor FET -based gas sensors have shown to be able to measure VOCs very accurately in low concentrations Bastuck thesis 2009 The metabolism in cancer cells vastly differs from that of healthy cells Elevated glycolysis leads to increases in lactate and fumarate metabolites resulting in altered VOC abundances in exhaled breath Experimental data indicate that the detection of VOCs released by various cancer cells may be useful in early diagnoses of cancer In patients with ovarian cancer analyzes of specific VOC s in blood has shown promising results to discriminate patient with ovarian cancer from healthy women Horvath The investigators have very recently in 37 patients out 38 with ovarian cancer found VOC indicating cancer which indicates a preliminary sensitivity of 97 In the total material of 68 analyzed samples 3 false positive results were found which indicates a specificity of 90 In a population with 1 malignancy the positive predictive value would be almost 10 and negative predictive value 999
In the current study samples from more ovarian cancer patients will be included and also samples from patients with other cancer types totally 245 patients of which 50 ovarian cancers The aim will be to see if good sensitivity and specificity can be achived with larger patient population same or better values than in the previous study Special focus will be put on early stages of ovarian cancer as well as borderline tumours The investigators aim also to see how distinct is VOC pattern for ovarian cancer compared to the VOC patterns for the other cancer forms Finally the study will give preliminary answer if VOC patterns for the other types of cancer ie breast colorectal bladder endometrie cervix is specific so it could be used in the future for development of dedicated diagnostic tools for those diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None