Ovarian CancerOva-seqNCT05030805
Transcriptional Map of Ovarian Cancer at the Single Cell Level
An observational study of Ovarian Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In 2020, epithelial ovarian cancer (EOC) accounts for 313,959 new cases and 207,252 deaths worldwide. The standardized 5-year net survival of a woman with EOC is 44% for cases diagnosed between 2005-2010. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an ovarian cancer
Who may be able to join
- Women of legal age (≥ 18 years)
- With an ovarian cancer confirmed by anatomopathological analysis
- Operated in the gynecology department of the Strasbourg University Hospital between 2021 and 2024
- Patients having given their agreement to participate in the present trial and to the constitution of the collection of biological samples
Who cannot join
- Chronic inflammatory disease (Lupus, rheumatoid arthritis, chronic inflammatory bowel disease, etc.)
- History of immunotherapy treatment (anti PDL1...)
- Previous appendixctomy for another reason
- Impossibility to give the patient informed information (subject in an emergency situation, difficulties in understanding, language barrier, altered cognitive abilities)
- Patient under legal protection or tutorship or curatorship.
- Pregnant patient, breastfeeding
- Persons deprived of liberty by judicial or administrative decision.
- Persons under forced psychiatric care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service Gynécologie Obstétrique, Hôpital de Hautepierre
Strasbourg, Alsace, 67000
Chérif AKLADIOS, MD, PhD
About this study
In 2020, epithelial ovarian cancer (EOC) accounts for 313,959 new cases and 207,252 deaths worldwide. The standardized 5-year net survival of a woman with EOC is 44% for cases diagnosed between 2005-2010. This is because 2 out of 3 cancers are found at an advanced stage with invasion beyond the ovaries to the entire peritoneum or distant metastasis. Treatment of EOC is currently based on platinum-based chemotherapy combined with paclitaxel and maximal cytoreduction surgery. Newer combination therapies may be introduced such as bevacizumab and oral poly ADP-ribose polymerase (PARP) inhibitors. Despite the combination of different therapeutic modes, the 5-year survival has not progressed much since the 1980s. The development of new and more effective therapies is essential but requires a better understanding of cancer heterogeneity and the identification of new therapeutic targets.
Cancer heterogeneity results from genetic and transcriptional variations between tumors but also between cells of the same tumor. This heterogeneity has an impact on the development of the tumor and its resistance to treatment. One of the methods to study this heterogeneity is single cell RNA sequencing (scRNAseq) which allows to analyze individually and simultaneously the gene expression (transcriptomics) of thousands of cells. Studies on EOC using this technique have already been performed but they were based on small numbers with very different tumor types and stages.
Read more
The objective of this protocol is to characterize by scRNA-seq the architecture and microenvironment of primary and secondary tumors of 50 patients with EOC at the single cell level and to correlate the data with the clinical characteristics of the patients, especially during recurrence and/or chemoresistance, in order to identify the molecular parameters allowing tumor cells to acquire survival, invasion, metastasis and chemoresistance capacity as well as to carry out the inventory of cell populations within the different sites of EOC. We will also analyze the interaction between tumor cells and the microenvironment, by studying on the one hand the involvement of immune cells in the antitumor response and on the other hand how tumor cells modulate the microenvironment to make it permissive to the development of the EOC. We will compare the data obtained for each patient with healthy tissue (from the same patient) in order to determine the common and specific tumor molecular signatures in EOC, the latter point allowing us to evaluate the intra and inter-patient variability. Similarly, the comparison of the transcriptomic profile of the same tumor subtype in several patients will allow us to determine if certain transcriptional perturbations are ubiquitous. The identification of these common pathways would allow the discovery of potential therapeutic targets.
Furthermore, the molecular processes leading to chemoresistance are still unknown. We will investigate whether known chemoresistance markers are present in tumor cells from primary sites and whether their presence correlates with the response to treatment in patients. We will also study the molecular mechanisms of resistance to treatment in our patients which will ultimately allow the development of new therapies. We will also try to find new prognostic markers which is made possible by the clinical follow-up of the patients.
The existence of this heterogeneity will be confirmed by complementary genetic analyses of the genome and exome (search for mutations, variation in gene copy number or chromosome copy number, epigenetic effects) by different molecular biology techniques (qPCR, NGS sequencing) and the markers that will be identified can be confirmed by histochemical analysis.
Read the detailed description
After tumor stage determination by the pathology department the fresh tumor samples will be prepared for the single cell preparation.. The samples will be transported in a cold transport solution (MACS Storage tissue, Miltenyi). These samples will be used for library preparation using the Chromium Controller (10X Genomics) and sequencing using the NextSeq550 system (Illumina) as well as for HLA-bound neoantigen identification by mass spectrometry. After data analysis by bioinformatics, we will study the transcriptome of each identified cell population. The identified markers will be confirmed by histochemical and molecular biological analysis.
- Conditions
- Ovarian Cancer
- Keywords
- cancer heterogeneity, single cell RNA sequencing, neoantigens, mass spectrometry
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular heterogeneity in ovarian cancer
We will study the cellular populations constituting ovarian tumors by comparing the existing cellular heterogeneity between patients (inter-patient) but also within the same patient, between primary and secondary sites on the one hand and within the same tumor tissue on the other hand (intra-patient) as well as the comparison with tissue considered as healthy between patients.
Measured: Within 24 hours of receiving the tissue from the surgery
Secondary outcomes (1)
Neoantigens study
Neoantigens present on the surface of tumor cells will be isolated by immunoprecipitation from cell lysates and their nature will be determined by LC-MS/MS. These proteomic results will be compared to the transcriptomic results by single cell sequencing obtained in the main objective.
Measured: Immediately at the time of the reception of the tissues resulting from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 May 2022
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030805
- Sponsor's protocol ID
- 8180
- Acronym
- Ova-seq
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptional Map of Ovarian Cancer at the Single Cell Level
- ClinicalTrials.gov ID
- NCT05030805
- Acronym / sponsor ID
- Ova-seq / 8180
- Conditions
- Ovarian Cancer
- Keywords
- cancer heterogeneity, single cell RNA sequencing, neoantigens, mass spectrometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 1 Sep 2021 (actual)
- 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.
In 2020, epithelial ovarian cancer (EOC) accounts for 313,959 new cases and 207,252 deaths worldwide. The standardized 5-year net survival of a woman with EOC is 44% for cases diagnosed between 2005-2010. This is because 2 out of 3 cancers are found at an advanced stage with invasion beyond the ovaries to the entire peritoneum or distant metastasis. Treatment of EOC is currently based on platinum-based chemotherapy combined with paclitaxel and maximal cytoreduction surgery. Newer combination therapies may be introduced such as bevacizumab and oral poly ADP-ribose polymerase (PARP) inhibitors. Despite the combination of different therapeutic modes, the 5-year survival has not progressed much since the 1980s. The development of new and more effective therapies is essential but requires a better understanding of cancer heterogeneity and the identification of new therapeutic targets.
Cancer heterogeneity results from genetic and transcriptional variations between tumors but also between cells of the same tumor. This heterogeneity has an impact on the development of the tumor and its resistance to treatment. One of the methods to study this heterogeneity is single cell RNA sequencing (scRNAseq) which allows to analyze individually and simultaneously the gene expression (transcriptomics) of thousands of cells. Studies on EOC using this technique have already been performed but they were based on small numbers with very different tumor types and stages.
The objective of this protocol is to characterize by scRNA-seq the architecture and microenvironment of primary and secondary tumors of 50 patients with EOC at the single cell level and to correlate the data with the clinical characteristics of the patients, especially during recurrence and/or chemoresistance, in order to identify the molecular parameters allowing tumor cells to acquire survival, invasion, metastasis and chemoresistance capacity as well as to carry out the inventory of cell populations within the different sites of EOC. We will also analyze the interaction between tumor cells and the microenvironment, by studying on the one hand the involvement of immune cells in the antitumor response and on the other hand how tumor cells modulate the microenvironment to make it permissive to the development of the EOC. We will compare the data obtained for each patient with healthy tissue (from the same patient) in order to determine the common and specific tumor molecular signatures in EOC, the latter point allowing us to evaluate the intra and inter-patient variability. Similarly, the comparison of the transcriptomic profile of the same tumor subtype in several patients will allow us to determine if certain transcriptional perturbations are ubiquitous. The identification of these common pathways would allow the discovery of potential therapeutic targets.
Furthermore, the molecular processes leading to chemoresistance are still unknown. We will investigate whether known chemoresistance markers are present in tumor cells from primary sites and whether their presence correlates with the response to treatment in patients. We will also study the molecular mechanisms of resistance to treatment in our patients which will ultimately allow the development of new therapies. We will also try to find new prognostic markers which is made possible by the clinical follow-up of the patients.
The existence of this heterogeneity will be confirmed by complementary genetic analyses of the genome and exome (search for mutations, variation in gene copy number or chromosome copy number, epigenetic effects) by different molecular biology techniques (qPCR, NGS sequencing) and the markers that will be identified can be confirmed by histochemical analysis.
Detailed description
After tumor stage determination by the pathology department the fresh tumor samples will be prepared for the single cell preparation.. The samples will be transported in a cold transport solution (MACS Storage tissue, Miltenyi). These samples will be used for library preparation using the Chromium Controller (10X Genomics) and sequencing using the NextSeq550 system (Illumina) as well as for HLA-bound neoantigen identification by mass spectrometry. After data analysis by bioinformatics, we will study the transcriptome of each identified cell population. The identified markers will be confirmed by histochemical and molecular biological analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an ovarian cancer
Key inclusion criteria (4 listed)
- Women of legal age (≥ 18 years)
- With an ovarian cancer confirmed by anatomopathological analysis
- Operated in the gynecology department of the Strasbourg University Hospital between 2021 and 2024
- Patients having given their agreement to participate in the present trial and to the constitution of the collection of biological samples
Key exclusion criteria (8 listed)
- Chronic inflammatory disease (Lupus, rheumatoid arthritis, chronic inflammatory bowel disease, etc.)
- History of immunotherapy treatment (anti PDL1...)
- Previous appendixctomy for another reason
- Impossibility to give the patient informed information (subject in an emergency situation, difficulties in understanding, language barrier, altered cognitive abilities)
- Patient under legal protection or tutorship or curatorship.
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
Cellular heterogeneity in ovarian cancer
Time frame: Within 24 hours of receiving the tissue from the surgery
We will study the cellular populations constituting ovarian tumors by comparing the existing cellular heterogeneity between patients (inter-patient) but also within the same patient, between primary and secondary sites on the one hand and within the same tumor tissue on the other hand (intra-patient) as well as the comparison with tissue considered as healthy between patients.
1 secondary outcome
Neoantigens study
Time frame: Immediately at the time of the reception of the tissues resulting from the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cherif Akladios, MD (3 88 12 74 55 ext. +33, Cherif.AKLADIOS@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular heterogeneity in ovarian cancer (time frame: Within 24 hours of receiving the tissue from the surgery). 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 22 Aug 2022.