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This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer,and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
The goal of this study is to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a single-arm, single-center prospective clinical study.
After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment,If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA will be tested for genetic variation based on next-generation sequencing (NGS).
Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin) and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment,If necessary, Peripheral blood samples also be collected after 2 cycles of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated liposomal doxorubicin | Drug | All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the consistency of circulating tumor DNA with CT scan | measuring the mutations of TP53,reporting the changes from baseline to 3 weeks after the first cycle, contrasting with CT scan changes,calculating Kappa value,and conducting a intrarater reliability | at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2(each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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platinum-resistant ovarian cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Wen, MD | Contact | +86-021-64175590 ext 81000 | wenhao@shca.org.cn | |
| Xiaohua Wu, MD | Contact | +86-021-64175590 ext 81000 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| C041277 | 1-dodecylpyridoxal |
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peripheral blood
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |