Malignant TumorsNCT07201259
Exploring Gut Microbiome Differences in Female Cancer Patients With Varied Ovarian Function and Fertility Outcomes Following Immune Checkpoint Inhibitor Therapy
An observational study of Malignant Tumors, run by West China Second University Hospital at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the impact of Immune Checkpoint Inhibitor (ICI) treatment on ovarian function and fertility, and to explore the role of gut microbiota in female cancer patients of reproductive age (18-38 years) receiving ICI therapy. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Malignant Tumors
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 10 Oct 2026
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients with malignant tumors scheduled to receive ICI or combination therapy including ICI at the Department of Biological Therapy, West China Hospital, Sichuan University between September 2025 and May 2026
Who may be able to join
- Collect serum hormone levels post-ICIs treatment to observe the impact of ICIs therapy on female patients.
- Informed consent must be obtained and documented at the research center prior to initiating any trial procedures.
- Female patients aged 18-38 years.
- Patients with histologically confirmed solid tumors or soft tissue sarcomas diagnosed via open surgery, laparoscopic surgery, or core needle biopsy.
- Patients scheduled to receive ICIs therapy or combination therapy including ICIs;
- Normal ovarian function and fertility prior to treatment, defined as regular menstrual cycles, normal serum FSH, LH, E2, P, and AMH levels, and normal gynecological ultrasound findings;
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- No use of sex hormone medications within 6 months prior to enrollment, including but not limited to estrogens, anti-estrogens hormones, hormonal contraceptives, etc.;
- No use of antibiotics or probiotics within 3 months prior to enrollment;
- Availability of blood and stool specimens before and after treatment, with the subject's consent to provide these specimens to the central laboratory for study purposes, including but not limited to: i. Potential gut microbiota-related research. ii. Potential metabolite-related research;
- Expected survival >12 weeks;
- ECOG performance status 0-2;
- Adequate organ function, including:
- Bone marrow function: Neutrophil count ≥1500/µL; Platelet count ≥100,000/ µL; Hemoglobin ≥10g/dL
- Liver function: Total bilirubin ≤1.5 times upper limit of normal (ULN) or direct bilirubin ≤1.0 times ULN; AST and ALT ≤2.5 times ULN, must be ≤5 times ULN if liver metastases present
- Renal function: Serum creatinine ≤1.5 times ULN, or creatinine clearance
- 60 mL/min (calculated using Cockcroft-Gault formula) ;
- Understand the trial protocol and have the ability to comply with the trial plan throughout its duration, including cooperating with any required treatments, examinations, tests, follow-ups, and questionnaires;
- Patient is willing to cooperate with ICIs treatment and subsequent follow-up.
Who cannot join
- Individuals involved in the planning or implementation of the study;
- Concurrent use of other tumor treatment modalities during the study, including but not limited to: chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other investigational therapies;
- History of bilateral ovarian-related surgery;
- Patients with prior radiotherapy or chemotherapy causing irreversible damage to ovarian function;
- Individuals with known allergy to ICIs or their components;
- Patients with known non-response to immunomodulatory therapy;
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- Patients with unexplained menstrual irregularities or long-term hormone medication use;
- Patients with chronic gastrointestinal disease or known dysbiosis (e.g., Crohn's disease, ulcerative colitis);
- Patients who frequently consume fermented foods;
- Patients who underwent major surgery within 3 weeks prior to study initiation or have not yet recovered from surgery;
- Subjects with other malignancies within the past 3 years;
- Patients with severe, uncontrolled medical conditions or those deemed by the investigator to be generally unsuitable for study participation, including but not limited to: active viral infections such as HIV, hepatitis B, hepatitis C; severe cardiovascular disease, uncontrolled ventricular arrhythmias, myocardial infarction within the past 3 months; uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other psychiatric conditions affecting informed consent; uncontrolled hypertension despite medication; immunodeficiency (excluding splenectomy) or other conditions the investigator deems likely to expose the subject to high toxicity risk;
- Any history or current clinical evidence suggesting potential for confounding study results, compromising patient compliance throughout the study, or acting against the patient's best interests;
- Receipt of platelet or red blood cell transfusion within 3 days prior to initiation of study drug treatment;
- Pregnant or lactating patients, or patients planning pregnancy during the study period.
- Clinically unresolved prior treatment toxicity (≥ Grade 2, excluding alopecia, neuropathy, lymphopenia, or skin hypopigmentation);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital
Chengdu, Sichuan, 610041
Xuelei Ma, +86 134 0841 0416, drmaxuelei@gmail.com
About this study
The goal of this observational study is to evaluate the impact of Immune Checkpoint Inhibitor (ICI) treatment on ovarian function and fertility, and to explore the role of gut microbiota in female cancer patients of reproductive age (18-38 years) receiving ICI therapy. The main questions it aims to answer are:
Does ICI treatment alter serum hormone levels (FSH, LH, E2, P, AMH) associated with ovarian function and fertility?
Read more
Are there differences in gut microbiota composition and metabolites between patients with different ovarian function and fertility outcomes after ICI treatment?
What are the potential mechanisms by which gut microbiota influences ovarian function and fertility in patients receiving ICIs?
Researchers will compare patients with preserved ovarian function versus those with impaired ovarian function after ICI treatment to identify differences in gut microbiota and metabolic profiles.
Participants will:
Provide blood samples (10 ml per collection) at enrollment and after each of the 6 treatment cycles for hormone level testing and potential future analyses.
Provide stool samples at the same time points for gut microbiota metagenomic sequencing and metabolite analysis.
Undergo regular clinical assessments and follow-ups as part of their standard ICI treatment.
- Conditions
- Malignant Tumors
- Being tested
- No Intervention: Observational Cohort
- Keywords
- immune checkpoint inhibitors, female, ovarian function, fertility
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| ICI or ICI combined treatment | Inclusion criteria:
1. Informed consent must be obtained and documented at the research center prior to initiating any trial procedures.
2. Female patients aged 18-38 years.
3. Patients with histologically confirmed solid tumors or soft tissue sarcomas diagnosed via open surgery, laparoscopic surgery, or core needle biopsy.
4. Patients scheduled to receive ICIs therapy or combination therapy including ICIs;
5. Normal ovarian function and fertility prior to treatment, defined as regular menstrual cycles, normal serum FSH, LH, E2, P, and AMH levels, and normal gynecological ultrasound findings;
6. No use of sex hormone medications within 6 months prior to enrollment, including but not limited to estrogens, anti-estrogens hormones, hormonal contraceptives, etc.;
7. No use of antibiotics or probiotics within 3 months prior to enrollment;
8. Availability of blood and stool specimens before and after Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle-stimulating hormone
Serum levels of Follicle-stimulating hormone
Measured: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Luteinizing hormone
Serum levels of Luteinizing hormone
Measured: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Estradiol
Serum levels of Estradiol
Measured: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Progesterone
Serum levels of Progesterone
Measured: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Anti-Müllerian hormone
Serum levels of Anti-Müllerian hormone
Measured: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Gut microbiota composition
Analyzing gut microbiota composition using metagenomic data from patient feces
Measured: At the enrollment and the end of Cycle 6 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start10 Oct 2025 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengtao Zhou, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201259
- Sponsor's protocol ID
- 2025（1695）
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Serum levels of FSH, LH, E2, P, and AMH hormones, along with fecal metagenomic sequencing data from patients, will be publicly shared at NCBI database.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Gut Microbiome Differences in Female Cancer Patients With Varied Ovarian Function and Fertility Outcomes Following Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT07201259
- Acronym / sponsor ID
- 2025（1695）
- Conditions
- Malignant Tumors
- Keywords
- immune checkpoint inhibitors, female, ovarian function, fertility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
The goal of this observational study is to evaluate the impact of Immune Checkpoint Inhibitor (ICI) treatment on ovarian function and fertility, and to explore the role of gut microbiota in female cancer patients of reproductive age (18-38 years) receiving ICI therapy. The main questions it aims to answer are:
Does ICI treatment alter serum hormone levels (FSH, LH, E2, P, AMH) associated with ovarian function and fertility?
Are there differences in gut microbiota composition and metabolites between patients with different ovarian function and fertility outcomes after ICI treatment?
What are the potential mechanisms by which gut microbiota influences ovarian function and fertility in patients receiving ICIs?
Researchers will compare patients with preserved ovarian function versus those with impaired ovarian function after ICI treatment to identify differences in gut microbiota and metabolic profiles.
Participants will:
Provide blood samples (10 ml per collection) at enrollment and after each of the 6 treatment cycles for hormone level testing and potential future analyses.
Provide stool samples at the same time points for gut microbiota metagenomic sequencing and metabolite analysis.
Undergo regular clinical assessments and follow-ups as part of their standard ICI treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICI or ICI combined treatment | – | Other: No Intervention: Observational CohortInclusion criteria: 1. Informed consent must be obtained and documented at the research center prior to initiating any trial procedures. 2. Female patients aged 18-38 years. 3. Patients with histologically confirmed solid tumors or soft tissue sarcomas diagnosed via open surgery, laparoscopic surgery, or core needle biopsy. 4. Patients scheduled to receive ICIs therapy or combination therapy including ICIs; 5. Normal ovarian function and fertility prior to treatment, defined as regular menstrual cycles, normal serum FSH, LH, E2, P, and AMH levels, and normal gynecological ultrasound findings; 6. No use of sex hormone medications within 6 months prior to enrollment, including but not limited to estrogens, anti-estrogens hormones, hormonal contraceptives, etc.; 7. No use of antibiotics or probiotics within 3 months prior to enrollment; 8. Availability of blood and stool specimens before and after |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients with malignant tumors scheduled to receive ICI or combination therapy including ICI at the Department of Biological Therapy, West China Hospital, Sichuan University between September 2025 and May 2026
Key inclusion criteria (18 listed)
- Collect serum hormone levels post-ICIs treatment to observe the impact of ICIs therapy on female patients.
- Informed consent must be obtained and documented at the research center prior to initiating any trial procedures.
- Female patients aged 18-38 years.
- Patients with histologically confirmed solid tumors or soft tissue sarcomas diagnosed via open surgery, laparoscopic surgery, or core needle biopsy.
- Patients scheduled to receive ICIs therapy or combination therapy including ICIs;
Key exclusion criteria (16 listed)
- Individuals involved in the planning or implementation of the study;
- Concurrent use of other tumor treatment modalities during the study, including but not limited to: chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other investigational therapies;
- History of bilateral ovarian-related surgery;
- Patients with prior radiotherapy or chemotherapy causing irreversible damage to ovarian function;
- Individuals with known allergy to ICIs or their components;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | ICI or ICI combined treatment |
Primary outcome
Follicle-stimulating hormone
Time frame: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Serum levels of Follicle-stimulating hormone
Luteinizing hormone
Time frame: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Serum levels of Luteinizing hormone
Estradiol
Time frame: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Serum levels of Estradiol
Progesterone
Time frame: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Serum levels of Progesterone
Anti-Müllerian hormone
Time frame: At the enrollment and the end of Cycle 6( each cycle is 28 days)
Serum levels of Anti-Müllerian hormone
Gut microbiota composition
Time frame: At the enrollment and the end of Cycle 6 (each cycle is 28 days)
Analyzing gut microbiota composition using metagenomic data from patient feces
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 1 Oct 2025.
- Individual participant dataSharing planned: Yes. Serum levels of FSH, LH, E2, P, and AMH hormones, along with fecal metagenomic sequencing data from patients, will be publicly shared at NCBI database.
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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 Malignant Tumors, run by West China Second University Hospital at 1 site in China.
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 18 inclusion and 16 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: opening soon, as of the sponsor's last update on 1 Oct 2025. 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 China. 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 Shengtao Zhou (+86 135 5107 0137, taotaovip2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicle-stimulating hormone (time frame: At the enrollment and the end of Cycle 6( each cycle is 28 days)). The study lists 6 primary outcomes in all. 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 1 Oct 2025.